🔍 RecallPedia

GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission

Class I - Dangerous
🏥 Medical Devices Recalled: December 18, 2024 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    1) 5376204-70-54-2: UDI/DI N/A, System ID NT4011, Serial Number 131640HL5; UDI/DI N/A, System ID NT1023, Serial Number 154472HL5; UDI/DI N/A, System ID NT4003, Serial Number 128062HL7; UDI/DI N/A, System ID NT4005, Serial Number 128536HL0; UDI/DI N/A, System ID NT1022, Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A, System ID 83131625480, Serial Number T27G15012/131277HL6; UDI/DI N/A, System ID 83119512125, Serial Number T2AG14038/0; UDI/DI N/A, System ID 83151204341, Serial Number T27G1600025/0; UDI/DI N/A, System ID 83153611901, Serial Number T27G1700030/147506HL0; UDI/DI N/A, System ID 83136989873, Serial Number T27G15006/GLX-TAN-03716; UDI/DI N/A, System ID 83114701360, Serial Number T2AG14036/112879HL2; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700034/150126HL1; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700033/150126HL1; UDI/DI N/A, System ID Not Available, Serial Number T27G15005/126820HL0; UDI/DI N/A, System ID 600002NM01, Serial Number T27G15004/126534HL7; UDI/DI N/A, System ID 083026806832815, Serial Number T2AG14035/148BH7; UDI/DI N/A, System ID Not Available, Serial Number T2AG14037/112809HL9; UDI/DI N/A, System ID 0835260017, Serial Number T2AG14039/115651HL2; UDI/DI N/A, System ID 5512MI0001, Serial Number T27G15011/130994HL7; UDI/DI N/A, System ID NT5002, Serial Number T27G16021/136626HL9; UDI/DI N/A, System ID NT5003, Serial Number T27G16023/ ; UDI/DI N/A, System ID Not Available, Serial Number T27G16022/137922HL1; UDI/DI N/A, System ID 85150299222, Serial Number T27G1600026/140419HL3; UDI/DI N/A, System ID Not Available, Serial Number T27G15014; UDI/DI N/A, System ID Not Available, Serial Number T27G15015; UDI/DI N/A, System ID Not Available, Serial Number T27G1600027; UDI/DI N/A, System ID Not Available, Serial Number T27G1600028; UDI/DI N/A, System ID Not Available, Serial Number T27G1600029; UDI/DI N/A, System ID Not Available, Serial Number T27G1700037. 3) H2402AC: UDI/DI 840682140904, System ID PK1335NM04, Serial Number NT28G1800003; UDI/DI 840682140904, System ID PK1480NM01, Serial Number NT28G1800004; UDI/DI 840682140904, System ID Not Available, Serial Number NT28G1800002; UDI/DI N/A, System ID Not Available, Serial Number T28G1800005/164844HL3; UDI/DI N/A, System ID Not Available, Serial Number T28G1800006/165131HL4; UDI/DI N/A, System ID Not Available, Serial Number T28G15001; UDI/DI N/A, System ID Not Available, Serial Number T28G15002; UDI/DI N/A, System ID Not Available, Serial Number T28G16003; UDI/DI N/A, System ID Not Available, Serial Number T28G16004; UDI/DI N/A, System ID Not Available, Serial Number T28G16007; UDI/DI N/A, System ID Not Available, Serial Number T28G1600008; UDI/DI N/A, System ID Not Available, Serial Number T28G15002N1; UDI/DI N/A, System ID Not Available, Serial Number T28G1600010; UDI/DI N/A, System ID Not Available, Serial Number T28G1600011; UDI/DI N/A, System ID Not Available, Serial Number T28G1700013; UDI/DI N/A, System ID Not Available, Serial Number T28G1700014; UDI/DI N/A, System ID Not Available, Serial Number T28G1700015; UDI/DI N/A, System ID Not Available, Serial Number T28G1700016; UDI/DI N/A, System ID Not Available, Serial Number T28G1700017; UDI/DI N/A, System ID Not Available, Serial Number T28G1700018; UDI/DI N/A, System ID Not Available, Serial Number T28G1700019; UDI/DI N/A, System ID Not Available, Serial Number T28G1700020; UDI/DI N/A, System ID Not Available, Serial Number T28G1700021; UDI/DI N/A, System ID Not Available, Serial Number T28G1700022; UDI/DI N/A, System ID PK1031NM04, Serial Number T28G1800003/160874HL4; UDI/DI N/A, System ID SA2385NM01, Serial Number T28G1800007/166055HL4; UDI/DI N/A, System ID SA1013MN02, Serial Number T28G1800023/159111HL4; UDI/DI N/A, System ID Not Available, Serial Number T28G1800002/159885HL3; UDI/DI N/A, System ID Not Available, Serial Number T28G1800008/166378HL0; UDI/DI N/A, System ID Not Available, Serial Number T28G16005/135524HL7; UDI/DI N/A, System ID 416494D670A, Serial Number T28G16006/0. 4) H3100AH: UDI/DI 840682121194, System ID Not Available, Serial Number PROV27138; UDI/DI 840682121194, System ID 604875D670A, Serial Number PROV27140; UDI/DI 840682121194, System ID 00137NUC06, Serial Number PROV27144; UDI/DI 840682121194, System ID 562826D670NM, Serial Number PROV27146; UDI/DI 840682121194, System ID Not Available, Serial Number PROV27148; UDI/DI 840682121194, System ID 815599D670, Serial Number PROV27149; UDI/DI 840682121194, System ID 250635D670, Serial Number PROV27152; UDI/DI 840682121194, System ID 614257D670CT, Serial Number PROV27155; UDI/DI 840682121194, System ID 720847NM3, Serial Number PROV27157; UDI/DI 840682121194, System ID 509363NM, Serial Number PROW27162; UDI/DI 840682121194, System ID FI1052MN03, Serial Number PROW27165; UDI/DI 840682121194, System ID RU0004NM01, Serial Number PROW27168; UDI/DI 840682121194, System ID 720847NM2, Serial Number PROW27169; UDI/DI 840682121194, System ID 083026862453817, Serial Number PROW27170; UDI/DI 840682121194, System ID 082426210029, Serial Number PROW27172; UDI/DI 840682121194, System ID 720847NM1, Serial Number PROW27174; UDI/DI 840682121194, System ID 082426300001, Serial Number PROW27177; UDI/DI 840682121194, System ID 082426160059, Serial Number PROW27180; UDI/DI 840682121194, System ID 082426110016, Serial Number PROW27181; UDI/DI 840682121194, System ID 082426080028, Serial Number PROW27182; UDI/DI 840682121194, System ID 082426110015, Serial Number PROW27183; UDI/DI 840682121194, System ID 082426080029, Serial Number PROW27184; UDI/DI 840682121194, System ID 305575NMD670, Serial Number PROW27185; UDI/DI 840682121194, System ID 082426040074, Serial Number PROW27186; UDI/DI 840682121194, System ID 082426130050, Serial Number PROW27188; UDI/DI 840682121194, System ID 082426070045, Serial Number PROW27189; UDI/DI 840682121194, System ID 0853260166, Serial Number PROW27191; UDI/DI 840682121194, System ID 0853260167, Serial Number PROW27194; UDI/DI 840682121194, System ID 082426090048, Serial Number PROW27197; UDI/DI 840682121194, System ID 082426310031, Serial Number PROW27198; UDI/DI 840682121194, System ID 082426150041, Serial Number PROW27199; UDI/DI 840682121194, System ID 0828260035, Serial Number PROW27200; UDI/DI 840682121194, System ID 082426070048, Serial Number PROW27201; UDI/DI 840682121194, System ID 082426090050, Serial Number PROW27202; UDI/DI 840682121194, System ID 083045209826317, Serial Number PROW27203; UDI/DI 840682121194, System ID 0828260034, Serial Number PROW27206; UDI/DI 840682121194, System ID 082426210034, Serial Number PROX27209; UDI/DI 840682121194, System ID 082426190034, Serial Number PROX27210; UDI/DI 840682121194, System ID 082426160060, Serial Number PROX27211; UDI/DI 840682121194, System ID 082426140035, Serial Number PROX27212; UDI/DI 840682121194, System ID 082426030036, Serial Number PROX27213; UDI/DI 840682121194, System ID 082426070047, Serial Number PROX27214; UDI/DI 840682121194, System ID 082426110001, Serial Number PROX27215; UDI/DI 840682121194, System ID 082426100071, Serial Number PROX27216; UDI/DI 840682121194, System ID 082426100076, Serial Number PROX27217; UDI/DI 840682121194, System ID 082426210032, Serial Number PROX27218; UDI/DI 840682121194, System ID 082426150042, Serial Number PROX27219; UDI/DI 840682121194, System ID 082426230031, Serial Number PROX27220; UDI/DI 840682121194, System ID 082426110017, Serial Number PROX27221; UDI/DI 840682121194, System ID 082426280002, Serial Number PROX27222; UDI/DI 840682121194, System ID 082426250008, Serial Number PROX27224; UDI/DI 840682121194, System ID 082426190036, Serial Number PROX27226; UDI/DI 840682121194, System ID 082426090047, Serial Number PROX27227; UDI/DI 840682121194, System ID 082426030039, Serial Number PROX27228; UDI/DI 840682121194, System ID 082426020012, Serial Number PROX27229; UDI/DI 840682121194, System ID 082426230032, Serial Number PROX27230; UDI/DI 840682121194, System ID 082426140036, Serial Number PROX27231; UDI/DI 840682121194, System ID 082426200015, Serial Number PROX27232; UDI/DI 840682121194, System ID 082426120042, Serial Number PROX27233; UDI/DI N/A, System ID 562401D670NM, Serial Number PROV27156; UDI/DI N/A, System ID 510D670, Serial Number 27119; UDI/DI N/A, System ID 720SAND670, Serial Number 27008; UDI/DI N/A, System ID 860545D670, Serial Number 27129; UDI/DI N/A, System ID 727398D670, Serial Number 27021; UDI/DI N/A, System ID 352265D670, Serial Number 27110; UDI/DI N/A, System ID 217732D670, Serial Number 27100; UDI/DI N/A, System ID 630527NM670, Serial Number 27096; UDI/DI N/A, System ID 1000004258, Serial Number 27133; UDI/DI N/A, System ID 217223DISNM, Serial Number 27127; UDI/DI N/A, System ID 301496D670P, Serial Number 27073; UDI/DI N/A, System ID 240314D670NM, Serial Number 27092; UDI/DI N/A, System ID 207373NM670, Serial Number 27117; UDI/DI N/A, System ID 612467DSC670, Serial Number 27094; UDI/DI N/A, System ID 612467DSC670, Serial Number 27105; UDI/DI N/A, System ID NM538029, Serial Number 27102; UDI/DI N/A, System ID 573815D670B, Serial Number 27032; UDI/DI N/A, System ID 573756D670, Serial Number 27055; UDI/DI N/A, System ID 636344NM, Serial Number PROW27158; UDI/DI N/A, System ID 636916D670, Serial Number 27002; UDI/DI N/A, System ID 314996D670, Serial Number 27046; UDI/DI N/A, System ID 314996D670, Serial Number 27062; UDI/DI N/A, System ID AM13ORK48, Serial Number 27065; UDI/DI N/A, System ID 314BARNNM2, Serial Number 27071; UDI/DI N/A, System ID Not Available, Serial Number 27030; UDI/DI N/A, System ID 718854NMD670, Serial Number 27007; UDI/DI N/A, System ID Not Available, Serial Number 27093; UDI/DI N/A, System ID 513CCHB670, Serial Number 27049; UDI/DI N/A, System ID 405720D670, Serial Number 27088; UDI/DI N/A, System ID 918286DIS1, Serial Number 27017; UDI/DI N/A, System ID Not Available, Serial Number 27118; UDI/DI N/A, System ID 412623D670NM1, Serial Number 27106; UDI/DI N/A, System ID 605322D670, Serial Number 27025; UDI/DI N/A, System ID 214820NM670, Serial Number 27040; UDI/DI N/A, System ID 214857NM670A, Serial Number 27044; UDI/DI N/A, System ID 214857NM670B, Serial Number 27083; UDI/DI N/A, System ID Not Available, Serial Number 27045; UDI/DI N/A, System ID UW1NM670, Serial Number 27050; UDI/DI N/A, System ID UW2NM670, Serial Number 27057; UDI/DI N/A, System ID Not Available, Serial Number 27012; UDI/DI N/A, System ID NM1172AR, Serial Number PROX27225; UDI/DI N/A, System ID NM8730AR, Serial Number PROX27223; UDI/DI N/A, System ID 83138055929, Serial Number 27060; UDI/DI N/A, System ID 83149220086, Serial Number 27120; UDI/DI N/A, System ID AH4001NU02, Serial Number 27098; UDI/DI N/A, System ID 030355NU06, Serial Number 27064; UDI/DI N/A, System ID 030388NU08, Serial Number 27020; UDI/DI N/A, System ID 210001NU03, Serial Number 27047; UDI/DI N/A, System ID 080004NU16, Serial Number 27036; UDI/DI N/A, System ID 050045NU01, Serial Number 27048; UDI/DI N/A, System ID 060055NU11, Serial Number 27089; UDI/DI N/A, System ID 220826NU05, Serial Number 27132; UDI/DI N/A, System ID 110034NU06, Serial Number 27031; UDI/DI N/A, System ID 160070NU03, Serial Number 27041; UDI/DI N/A, System ID 030078NU20, Serial Number 27109; UDI/DI N/A, System ID 030028NU03, Serial Number 27091; UDI/DI N/A, System ID 110025NU01, Serial Number PROV27154; UDI/DI N/A, System ID NMPROV27147, Serial Number PROV27147; UDI/DI N/A, System ID NMPROX27208, Serial Number PROX27208; UDI/DI N/A, System ID NMPROW27190, Serial Number PROW27190; UDI/DI N/A, System ID BG4693NM01, Serial Number 27079; UDI/DI N/A, System ID 780492D670A, Serial Number 27081; UDI/DI N/A, System ID 780477D670A, Serial Number 27115; UDI/DI N/A, System ID 204726D671, Serial Number 27082; UDI/DI N/A, System ID 506544D670, Serial Number 27131; UDI/DI N/A, System ID 519663D670A, Serial Number 27051; UDI/DI N/A, System ID 519464BWD670, Serial Number 27124; UDI/DI N/A, System ID NM5641CL, Serial Number 27122; UDI/DI N/A, System ID NMPROW27205, Serial Number PROW27205; UDI/DI N/A, System ID 082426040068, Serial Number PROW27204; UDI/DI N/A, System ID 082426100075, Serial Number PROW27195; UDI/DI N/A, System ID 082426210030, Serial Number PROW27196; UDI/DI N/A, System ID 082426050017, Serial Number PROW27207; UDI/DI N/A, System ID 082426080030, Serial Number PROW27193; UDI/DI N/A, System ID NM27101, Serial Number 27101; UDI/DI N/A, System ID 600020NM01, Serial Number 27103; UDI/DI N/A, System ID DK1054NM04, Serial Number 27006; UDI/DI N/A, System ID NMPROV27141, Serial Number PROV27141; UDI/DI N/A, System ID M4159244, Serial Number 27054; UDI/DI N/A, System ID M4135189, Serial Number 27111; UDI/DI N/A, System ID X61014016, Serial Number 27116; UDI/DI N/A, System ID B4155430, Serial Number 27015; UDI/DI N/A, System ID B4195734, Serial Number 27052; UDI/DI N/A, System ID M40345214, Serial Number 27070; UDI/DI N/A, System ID A4166974, Serial Number 27004; UDI/DI N/A, System ID M4197673, Serial Number 27077; UDI/DI N/A, System ID M1106617, Serial Number 27125; UDI/DI N/A, System ID V2943419, Serial Number 27126; UDI/DI N/A, System ID 560496NU01, Serial Number 27080; UDI/DI N/A, System ID HC4387NU03, Serial Number 27001; UDI/DI N/A, System ID HAUG02NU05, Serial Number PROV27153; UDI/DI N/A, System ID 233637NU01, Serial Number PROW27163; UDI/DI N/A, System ID UHAN01NU12, Serial Number PROW27166; UDI/DI N/A, System ID GP1000NM05, Serial Number 27024; UDI/DI N/A, System ID IE1004MN01, Serial Number 27009; UDI/DI N/A, System ID IE1004MN02, Serial Number 27010; UDI/DI N/A, System ID IE1010MN03, Serial Number PROV27150; UDI/DI N/A, System ID IE1016NM01, Serial Number PROV27143; UDI/DI N/A, System ID IE1033NM01, Serial Number PROW27160; UDI/DI N/A, System ID A51622100, Serial Number 27066; UDI/DI N/A, System ID A51077100, Serial Number 27068; UDI/DI N/A, System ID A5805535, Serial Number 27014; UDI/DI N/A, System ID A5320163, Serial Number 27078; UDI/DI N/A, System ID A5114727, Serial Number 27013; UDI/DI N/A, System ID NT5001, Serial Number 27033; UDI/DI N/A, System ID 0850260157, Serial Number PROV27151; UDI/DI N/A, System ID 0850260156, Serial Number PROV27123; UDI/DI N/A, System ID 0850260154, Serial Number PROV27137; UDI/DI N/A, System ID 0850260158, Serial Number PROW27175; UDI/DI N/A, System ID 0850260143, Serial Number 27053; UDI/DI N/A, System ID 0850260191, Serial Number 27028; UDI/DI N/A, System ID LDD0438, Serial Number 27095; UDI/DI N/A, System ID AMS1332, Serial Number 27037; UDI/DI N/A, System ID HLM06300, Serial Number 27107; UDI/DI N/A, System ID NO1015MN18, Serial Number 27114; UDI/DI N/A, System ID NO1016MN38, Serial Number 27043; UDI/DI N/A, System ID NO1000MN08, Serial Number 27039; UDI/DI N/A, System ID 1557MI0005, Serial Number 27085; UDI/DI N/A, System ID 1557MI0007, Serial Number 27134; UDI/DI N/A, System ID PL2801NM01, Serial Number 27067; UDI/DI N/A, System ID PL1065NM01, Serial Number 27018; UDI/DI N/A, System ID NMPROV27142, Serial Number PROV27142; UDI/DI N/A, System ID RU0063NM01, Serial Number PROW27167; UDI/DI N/A, System ID RU1928NM02, Serial Number PROW27187; UDI/DI N/A, System ID SI4120NM01, Serial Number 27022; UDI/DI N/A, System ID ZA1247NM08, Serial Number PROW27179; UDI/DI N/A, System ID ZA2700NM01, Serial Number 27034; UDI/DI N/A, System ID ZA1046NM01, Serial Number 27063; UDI/DI N/A, System ID FEG51900, Serial Number 27112; UDI/DI N/A, System ID A205NU02, Serial Number PROW27161; UDI/DI N/A, System ID A205NU01, Serial Number PROW27159; UDI/DI N/A, System ID P003NU01, Serial Number 27130; UDI/DI N/A, System ID O005NU29, Serial Number 27074; UDI/DI N/A, System ID O005NU30, Serial Number 27086; UDI/DI N/A, System ID T002NU01, Serial Number 27061; UDI/DI N/A, System ID T002NU02, Serial Number 27099; UDI/DI N/A, System ID Z001NU08, Serial Number 27097; UDI/DI N/A, System ID O006NU01, Serial Number 27084; UDI/DI N/A, System ID AC001NU20, Serial Number 27035; UDI/DI N/A, System ID C028NU03, Serial Number 27023; UDI/DI N/A, System ID 502010NU01, Serial Number 27016; UDI/DI N/A, System ID 850020NU01, Serial Number 27058; UDI/DI N/A, System ID 850020NU02, Serial Number 27075; UDI/DI N/A, System ID 0853260146, Serial Number 27069; UDI/DI N/A, System ID 1573MI0009, Serial Number PROW27192; UDI/DI N/A, System ID 1573MI0005, Serial Number PROV27139; UDI/DI N/A, System ID 1573MI0002, Serial Number 27087; UDI/DI N/A, System ID 1573MI0003, Serial Number 27104; UDI/DI N/A, System ID 21019NUC01, Serial Number 27076; UDI/DI N/A, System ID 34418NUC01, Serial Number 27108; UDI/DI N/A, System ID 00249NUC03, Serial Number 27113; UDI/DI N/A, System ID 00440NUC17, Serial Number 27059; UDI/DI N/A, System ID 00318NUC20, Serial Number 27003; UDI/DI N/A, System ID 00100NUC05, Serial Number 27005; UDI/DI N/A, System ID 10738NUC01, Serial Number 27136; UDI/DI N/A, System ID 00141NUC13, Serial Number 27029; UDI/DI N/A, System ID 00243NUC24, Serial Number PROW27164; UDI/DI N/A, System ID 00380NUC03, Serial Number PROV27145; UDI/DI N/A, System ID 77588NUC05, Serial Number PROW27173; UDI/DI N/A, System ID 00262NUC05, Serial Number PROW27171; UDI/DI N/A, System ID 5973MI0008, Serial Number PROW27178; UDI/DI N/A, System ID UAB670, Serial Number 27011; UDI/DI N/A, System ID 479757NMOPT1, Serial Number 27019. 5) H3100XB: UDI/DI N/A, System ID Not Available, Serial Number 26046.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Reason for Recall:
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission

Product Codes/Lot Numbers:

1) 5376204-70-54-2: UDI/DI N/A, System ID NT4011, Serial Number 131640HL5; UDI/DI N/A, System ID NT1023, Serial Number 154472HL5; UDI/DI N/A, System ID NT4003, Serial Number 128062HL7; UDI/DI N/A, System ID NT4005, Serial Number 128536HL0; UDI/DI N/A, System ID NT1022, Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A, System ID 83131625480, Serial Number T27G15012/131277HL6; UDI/DI N/A, System ID 83119512125, Serial Number T2AG14038/0; UDI/DI N/A, System ID 83151204341, Serial Number T27G1600025/0; UDI/DI N/A, System ID 83153611901, Serial Number T27G1700030/147506HL0; UDI/DI N/A, System ID 83136989873, Serial Number T27G15006/GLX-TAN-03716; UDI/DI N/A, System ID 83114701360, Serial Number T2AG14036/112879HL2; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700034/150126HL1; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700033/150126HL1; UDI/DI N/A, System ID Not Available, Serial Number T27G15005/126820HL0; UDI/DI N/A, System ID 600002NM01, Serial Number T27G15004/126534HL7; UDI/DI N/A, System ID 083026806832815, Serial Number T2AG14035/148BH7; UDI/DI N/A, System ID Not Available, Serial Number T2AG14037/112809HL9; UDI/DI N/A, System ID 0835260017, Serial Number T2AG14039/115651HL2; UDI/DI N/A, System ID 5512MI0001, Serial Number T27G15011/130994HL7; UDI/DI N/A, System ID NT5002, Serial Number T27G16021/136626HL9; UDI/DI N/A, System ID NT5003, Serial Number T27G16023/ ; UDI/DI N/A, System ID Not Available, Serial Number T27G16022/137922HL1; UDI/DI N/A, System ID 85150299222, Serial Number T27G1600026/140419HL3; UDI/DI N/A, System ID Not Available, Serial Number T27G15014; UDI/DI N/A, System ID Not Available, Serial Number T27G15015; UDI/DI N/A, System ID Not Available, Serial Number T27G1600027; UDI/DI N/A, System ID Not Available, Serial Number T27G1600028; UDI/DI N/A, System ID Not Available, Serial Number T27G1600029; UDI/DI N/A, System ID Not Available, Serial Number T27G1700037. 3) H2402AC: UDI/DI 840682140904, System ID PK1335NM04, Serial Number NT28G1800003; UDI/DI 840682140904, System ID PK1480NM01, Serial Number NT28G1800004; UDI/DI 840682140904, System ID Not Available, Serial Number NT28G1800002; UDI/DI N/A, System ID Not Available, Serial Number T28G1800005/164844HL3; UDI/DI N/A, System ID Not Available, Serial Number T28G1800006/165131HL4; UDI/DI N/A, System ID Not Available, Serial Number T28G15001; UDI/DI N/A, System ID Not Available, Serial Number T28G15002; UDI/DI N/A, System ID Not Available, Serial Number T28G16003; UDI/DI N/A, System ID Not Available, Serial Number T28G16004; UDI/DI N/A, System ID Not Available, Serial Number T28G16007; UDI/DI N/A, System ID Not Available, Serial Number T28G1600008; UDI/DI N/A, System ID Not Available, Serial Number T28G15002N1; UDI/DI N/A, System ID Not Available, Serial Number T28G1600010; UDI/DI N/A, System ID Not Available, Serial Number T28G1600011; UDI/DI N/A, System ID Not Available, Serial Number T28G1700013; UDI/DI N/A, System ID Not Available, Serial Number T28G1700014; UDI/DI N/A, System ID Not Available, Serial Number T28G1700015; UDI/DI N/A, System ID Not Available, Serial Number T28G1700016; UDI/DI N/A, System ID Not Available, Serial Number T28G1700017; UDI/DI N/A, System ID Not Available, Serial Number T28G1700018; UDI/DI N/A, System ID Not Available, Serial Number T28G1700019; UDI/DI N/A, System ID Not Available, Serial Number T28G1700020; UDI/DI N/A, System ID Not Available, Serial Number T28G1700021; UDI/DI N/A, System ID Not Available, Serial Number T28G1700022; UDI/DI N/A, System ID PK1031NM04, Serial Number T28G1800003/160874HL4; UDI/DI N/A, System ID SA2385NM01, Serial Number T28G1800007/166055HL4; UDI/DI N/A, System ID SA1013MN02, Serial Number T28G1800023/159111HL4; UDI/DI N/A, System ID Not Available, Serial Number T28G1800002/159885HL3; UDI/DI N/A, System ID Not Available, Serial Number T28G1800008/166378HL0; UDI/DI N/A, System ID Not Available, Serial Number T28G16005/135524HL7; UDI/DI N/A, System ID 416494D670A, Serial Number T28G16006/0. 4) H3100AH: UDI/DI 840682121194, System ID Not Available, Serial Number PROV27138; UDI/DI 840682121194, System ID 604875D670A, Serial Number PROV27140; UDI/DI 840682121194, System ID 00137NUC06, Serial Number PROV27144; UDI/DI 840682121194, System ID 562826D670NM, Serial Number PROV27146; UDI/DI 840682121194, System ID Not Available, Serial Number PROV27148; UDI/DI 840682121194, System ID 815599D670, Serial Number PROV27149; UDI/DI 840682121194, System ID 250635D670, Serial Number PROV27152; UDI/DI 840682121194, System ID 614257D670CT, Serial Number PROV27155; UDI/DI 840682121194, System ID 720847NM3, Serial Number PROV27157; UDI/DI 840682121194, System ID 509363NM, Serial Number PROW27162; UDI/DI 840682121194, System ID FI1052MN03, Serial Number PROW27165; UDI/DI 840682121194, System ID RU0004NM01, Serial Number PROW27168; UDI/DI 840682121194, System ID 720847NM2, Serial Number PROW27169; UDI/DI 840682121194, System ID 083026862453817, Serial Number PROW27170; UDI/DI 840682121194, System ID 082426210029, Serial Number PROW27172; UDI/DI 840682121194, System ID 720847NM1, Serial Number PROW27174; UDI/DI 840682121194, System ID 082426300001, Serial Number PROW27177; UDI/DI 840682121194, System ID 082426160059, Serial Number PROW27180; UDI/DI 840682121194, System ID 082426110016, Serial Number PROW27181; UDI/DI 840682121194, System ID 082426080028, Serial Number PROW27182; UDI/DI 840682121194, System ID 082426110015, Serial Number PROW27183; UDI/DI 840682121194, System ID 082426080029, Serial Number PROW27184; UDI/DI 840682121194, System ID 305575NMD670, Serial Number PROW27185; UDI/DI 840682121194, System ID 082426040074, Serial Number PROW27186; UDI/DI 840682121194, System ID 082426130050, Serial Number PROW27188; UDI/DI 840682121194, System ID 082426070045, Serial Number PROW27189; UDI/DI 840682121194, System ID 0853260166, Serial Number PROW27191; UDI/DI 840682121194, System ID 0853260167, Serial Number PROW27194; UDI/DI 840682121194, System ID 082426090048, Serial Number PROW27197; UDI/DI 840682121194, System ID 082426310031, Serial Number PROW27198; UDI/DI 840682121194, System ID 082426150041, Serial Number PROW27199; UDI/DI 840682121194, System ID 0828260035, Serial Number PROW27200; UDI/DI 840682121194, System ID 082426070048, Serial Number PROW27201; UDI/DI 840682121194, System ID 082426090050, Serial Number PROW27202; UDI/DI 840682121194, System ID 083045209826317, Serial Number PROW27203; UDI/DI 840682121194, System ID 0828260034, Serial Number PROW27206; UDI/DI 840682121194, System ID 082426210034, Serial Number PROX27209; UDI/DI 840682121194, System ID 082426190034, Serial Number PROX27210; UDI/DI 840682121194, System ID 082426160060, Serial Number PROX27211; UDI/DI 840682121194, System ID 082426140035, Serial Number PROX27212; UDI/DI 840682121194, System ID 082426030036, Serial Number PROX27213; UDI/DI 840682121194, System ID 082426070047, Serial Number PROX27214; UDI/DI 840682121194, System ID 082426110001, Serial Number PROX27215; UDI/DI 840682121194, System ID 082426100071, Serial Number PROX27216; UDI/DI 840682121194, System ID 082426100076, Serial Number PROX27217; UDI/DI 840682121194, System ID 082426210032, Serial Number PROX27218; UDI/DI 840682121194, System ID 082426150042, Serial Number PROX27219; UDI/DI 840682121194, System ID 082426230031, Serial Number PROX27220; UDI/DI 840682121194, System ID 082426110017, Serial Number PROX27221; UDI/DI 840682121194, System ID 082426280002, Serial Number PROX27222; UDI/DI 840682121194, System ID 082426250008, Serial Number PROX27224; UDI/DI 840682121194, System ID 082426190036, Serial Number PROX27226; UDI/DI 840682121194, System ID 082426090047, Serial Number PROX27227; UDI/DI 840682121194, System ID 082426030039, Serial Number PROX27228; UDI/DI 840682121194, System ID 082426020012, Serial Number PROX27229; UDI/DI 840682121194, System ID 082426230032, Serial Number PROX27230; UDI/DI 840682121194, System ID 082426140036, Serial Number PROX27231; UDI/DI 840682121194, System ID 082426200015, Serial Number PROX27232; UDI/DI 840682121194, System ID 082426120042, Serial Number PROX27233; UDI/DI N/A, System ID 562401D670NM, Serial Number PROV27156; UDI/DI N/A, System ID 510D670, Serial Number 27119; UDI/DI N/A, System ID 720SAND670, Serial Number 27008; UDI/DI N/A, System ID 860545D670, Serial Number 27129; UDI/DI N/A, System ID 727398D670, Serial Number 27021; UDI/DI N/A, System ID 352265D670, Serial Number 27110; UDI/DI N/A, System ID 217732D670, Serial Number 27100; UDI/DI N/A, System ID 630527NM670, Serial Number 27096; UDI/DI N/A, System ID 1000004258, Serial Number 27133; UDI/DI N/A, System ID 217223DISNM, Serial Number 27127; UDI/DI N/A, System ID 301496D670P, Serial Number 27073; UDI/DI N/A, System ID 240314D670NM, Serial Number 27092; UDI/DI N/A, System ID 207373NM670, Serial Number 27117; UDI/DI N/A, System ID 612467DSC670, Serial Number 27094; UDI/DI N/A, System ID 612467DSC670, Serial Number 27105; UDI/DI N/A, System ID NM538029, Serial Number 27102; UDI/DI N/A, System ID 573815D670B, Serial Number 27032; UDI/DI N/A, System ID 573756D670, Serial Number 27055; UDI/DI N/A, System ID 636344NM, Serial Number PROW27158; UDI/DI N/A, System ID 636916D670, Serial Number 27002; UDI/DI N/A, System ID 314996D670, Serial Number 27046; UDI/DI N/A, System ID 314996D670, Serial Number 27062; UDI/DI N/A, System ID AM13ORK48, Serial Number 27065; UDI/DI N/A, System ID 314BARNNM2, Serial Number 27071; UDI/DI N/A, System ID Not Available, Serial Number 27030; UDI/DI N/A, System ID 718854NMD670, Serial Number 27007; UDI/DI N/A, System ID Not Available, Serial Number 27093; UDI/DI N/A, System ID 513CCHB670, Serial Number 27049; UDI/DI N/A, System ID 405720D670, Serial Number 27088; UDI/DI N/A, System ID 918286DIS1, Serial Number 27017; UDI/DI N/A, System ID Not Available, Serial Number 27118; UDI/DI N/A, System ID 412623D670NM1, Serial Number 27106; UDI/DI N/A, System ID 605322D670, Serial Number 27025; UDI/DI N/A, System ID 214820NM670, Serial Number 27040; UDI/DI N/A, System ID 214857NM670A, Serial Number 27044; UDI/DI N/A, System ID 214857NM670B, Serial Number 27083; UDI/DI N/A, System ID Not Available, Serial Number 27045; UDI/DI N/A, System ID UW1NM670, Serial Number 27050; UDI/DI N/A, System ID UW2NM670, Serial Number 27057; UDI/DI N/A, System ID Not Available, Serial Number 27012; UDI/DI N/A, System ID NM1172AR, Serial Number PROX27225; UDI/DI N/A, System ID NM8730AR, Serial Number PROX27223; UDI/DI N/A, System ID 83138055929, Serial Number 27060; UDI/DI N/A, System ID 83149220086, Serial Number 27120; UDI/DI N/A, System ID AH4001NU02, Serial Number 27098; UDI/DI N/A, System ID 030355NU06, Serial Number 27064; UDI/DI N/A, System ID 030388NU08, Serial Number 27020; UDI/DI N/A, System ID 210001NU03, Serial Number 27047; UDI/DI N/A, System ID 080004NU16, Serial Number 27036; UDI/DI N/A, System ID 050045NU01, Serial Number 27048; UDI/DI N/A, System ID 060055NU11, Serial Number 27089; UDI/DI N/A, System ID 220826NU05, Serial Number 27132; UDI/DI N/A, System ID 110034NU06, Serial Number 27031; UDI/DI N/A, System ID 160070NU03, Serial Number 27041; UDI/DI N/A, System ID 030078NU20, Serial Number 27109; UDI/DI N/A, System ID 030028NU03, Serial Number 27091; UDI/DI N/A, System ID 110025NU01, Serial Number PROV27154; UDI/DI N/A, System ID NMPROV27147, Serial Number PROV27147; UDI/DI N/A, System ID NMPROX27208, Serial Number PROX27208; UDI/DI N/A, System ID NMPROW27190, Serial Number PROW27190; UDI/DI N/A, System ID BG4693NM01, Serial Number 27079; UDI/DI N/A, System ID 780492D670A, Serial Number 27081; UDI/DI N/A, System ID 780477D670A, Serial Number 27115; UDI/DI N/A, System ID 204726D671, Serial Number 27082; UDI/DI N/A, System ID 506544D670, Serial Number 27131; UDI/DI N/A, System ID 519663D670A, Serial Number 27051; UDI/DI N/A, System ID 519464BWD670, Serial Number 27124; UDI/DI N/A, System ID NM5641CL, Serial Number 27122; UDI/DI N/A, System ID NMPROW27205, Serial Number PROW27205; UDI/DI N/A, System ID 082426040068, Serial Number PROW27204; UDI/DI N/A, System ID 082426100075, Serial Number PROW27195; UDI/DI N/A, System ID 082426210030, Serial Number PROW27196; UDI/DI N/A, System ID 082426050017, Serial Number PROW27207; UDI/DI N/A, System ID 082426080030, Serial Number PROW27193; UDI/DI N/A, System ID NM27101, Serial Number 27101; UDI/DI N/A, System ID 600020NM01, Serial Number 27103; UDI/DI N/A, System ID DK1054NM04, Serial Number 27006; UDI/DI N/A, System ID NMPROV27141, Serial Number PROV27141; UDI/DI N/A, System ID M4159244, Serial Number 27054; UDI/DI N/A, System ID M4135189, Serial Number 27111; UDI/DI N/A, System ID X61014016, Serial Number 27116; UDI/DI N/A, System ID B4155430, Serial Number 27015; UDI/DI N/A, System ID B4195734, Serial Number 27052; UDI/DI N/A, System ID M40345214, Serial Number 27070; UDI/DI N/A, System ID A4166974, Serial Number 27004; UDI/DI N/A, System ID M4197673, Serial Number 27077; UDI/DI N/A, System ID M1106617, Serial Number 27125; UDI/DI N/A, System ID V2943419, Serial Number 27126; UDI/DI N/A, System ID 560496NU01, Serial Number 27080; UDI/DI N/A, System ID HC4387NU03, Serial Number 27001; UDI/DI N/A, System ID HAUG02NU05, Serial Number PROV27153; UDI/DI N/A, System ID 233637NU01, Serial Number PROW27163; UDI/DI N/A, System ID UHAN01NU12, Serial Number PROW27166; UDI/DI N/A, System ID GP1000NM05, Serial Number 27024; UDI/DI N/A, System ID IE1004MN01, Serial Number 27009; UDI/DI N/A, System ID IE1004MN02, Serial Number 27010; UDI/DI N/A, System ID IE1010MN03, Serial Number PROV27150; UDI/DI N/A, System ID IE1016NM01, Serial Number PROV27143; UDI/DI N/A, System ID IE1033NM01, Serial Number PROW27160; UDI/DI N/A, System ID A51622100, Serial Number 27066; UDI/DI N/A, System ID A51077100, Serial Number 27068; UDI/DI N/A, System ID A5805535, Serial Number 27014; UDI/DI N/A, System ID A5320163, Serial Number 27078; UDI/DI N/A, System ID A5114727, Serial Number 27013; UDI/DI N/A, System ID NT5001, Serial Number 27033; UDI/DI N/A, System ID 0850260157, Serial Number PROV27151; UDI/DI N/A, System ID 0850260156, Serial Number PROV27123; UDI/DI N/A, System ID 0850260154, Serial Number PROV27137; UDI/DI N/A, System ID 0850260158, Serial Number PROW27175; UDI/DI N/A, System ID 0850260143, Serial Number 27053; UDI/DI N/A, System ID 0850260191, Serial Number 27028; UDI/DI N/A, System ID LDD0438, Serial Number 27095; UDI/DI N/A, System ID AMS1332, Serial Number 27037; UDI/DI N/A, System ID HLM06300, Serial Number 27107; UDI/DI N/A, System ID NO1015MN18, Serial Number 27114; UDI/DI N/A, System ID NO1016MN38, Serial Number 27043; UDI/DI N/A, System ID NO1000MN08, Serial Number 27039; UDI/DI N/A, System ID 1557MI0005, Serial Number 27085; UDI/DI N/A, System ID 1557MI0007, Serial Number 27134; UDI/DI N/A, System ID PL2801NM01, Serial Number 27067; UDI/DI N/A, System ID PL1065NM01, Serial Number 27018; UDI/DI N/A, System ID NMPROV27142, Serial Number PROV27142; UDI/DI N/A, System ID RU0063NM01, Serial Number PROW27167; UDI/DI N/A, System ID RU1928NM02, Serial Number PROW27187; UDI/DI N/A, System ID SI4120NM01, Serial Number 27022; UDI/DI N/A, System ID ZA1247NM08, Serial Number PROW27179; UDI/DI N/A, System ID ZA2700NM01, Serial Number 27034; UDI/DI N/A, System ID ZA1046NM01, Serial Number 27063; UDI/DI N/A, System ID FEG51900, Serial Number 27112; UDI/DI N/A, System ID A205NU02, Serial Number PROW27161; UDI/DI N/A, System ID A205NU01, Serial Number PROW27159; UDI/DI N/A, System ID P003NU01, Serial Number 27130; UDI/DI N/A, System ID O005NU29, Serial Number 27074; UDI/DI N/A, System ID O005NU30, Serial Number 27086; UDI/DI N/A, System ID T002NU01, Serial Number 27061; UDI/DI N/A, System ID T002NU02, Serial Number 27099; UDI/DI N/A, System ID Z001NU08, Serial Number 27097; UDI/DI N/A, System ID O006NU01, Serial Number 27084; UDI/DI N/A, System ID AC001NU20, Serial Number 27035; UDI/DI N/A, System ID C028NU03, Serial Number 27023; UDI/DI N/A, System ID 502010NU01, Serial Number 27016; UDI/DI N/A, System ID 850020NU01, Serial Number 27058; UDI/DI N/A, System ID 850020NU02, Serial Number 27075; UDI/DI N/A, System ID 0853260146, Serial Number 27069; UDI/DI N/A, System ID 1573MI0009, Serial Number PROW27192; UDI/DI N/A, System ID 1573MI0005, Serial Number PROV27139; UDI/DI N/A, System ID 1573MI0002, Serial Number 27087; UDI/DI N/A, System ID 1573MI0003, Serial Number 27104; UDI/DI N/A, System ID 21019NUC01, Serial Number 27076; UDI/DI N/A, System ID 34418NUC01, Serial Number 27108; UDI/DI N/A, System ID 00249NUC03, Serial Number 27113; UDI/DI N/A, System ID 00440NUC17, Serial Number 27059; UDI/DI N/A, System ID 00318NUC20, Serial Number 27003; UDI/DI N/A, System ID 00100NUC05, Serial Number 27005; UDI/DI N/A, System ID 10738NUC01, Serial Number 27136; UDI/DI N/A, System ID 00141NUC13, Serial Number 27029; UDI/DI N/A, System ID 00243NUC24, Serial Number PROW27164; UDI/DI N/A, System ID 00380NUC03, Serial Number PROV27145; UDI/DI N/A, System ID 77588NUC05, Serial Number PROW27173; UDI/DI N/A, System ID 00262NUC05, Serial Number PROW27171; UDI/DI N/A, System ID 5973MI0008, Serial Number PROW27178; UDI/DI N/A, System ID UAB670, Serial Number 27011; UDI/DI N/A, System ID 479757NMOPT1, Serial Number 27019. 5) H3100XB: UDI/DI N/A, System ID Not Available, Serial Number 26046.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0893-2025

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