🔍 RecallPedia

GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E

Class I - Dangerous
🏥 Medical Devices Recalled: June 7, 2018 GE Medical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number, Serial Number (System ID) : 2226300, 000000000R4938 (256329MR2); 2226300, 000000000R5598 (256ALOPMR); N/A, N/A (334699MR); 2377062-2, 00000002547YR8 (256265HMR); 5107849, 00000274691MR5 (205487MR2); 46-294231G1, 0002005-0411-5 (870972E16); 46-294231G1, 002005-1201-35 (623583MR1); 2377062-2, 00000963660YM6 (480323MR1); 5107849-2, 00000278561MR6 (818445MR); 46-294231G1, 002004-1028-04 (3825); 2377062, 00000941225YM5 (626335MR); 46-294231G1, 002004-0913-01 (3591); 46-294231G1, 002005-1018-15 (352333MR3T); N/A, N/A (954587MR1); 46-294231G1, 002002-0605-11 (781340MR); 5107849, 266201MR3 (RADNETMR1585); 46-294231G1, 002005-0110-28 (313593MR02); 5308573, 00000292781MR2 (609890MR); 2214149-2, 00000010224GQ4 (732745MR); 2377062-2, 00000963098YM9 (607798MREXCT); N/A, N/A (516825MR); N/A, N/A (405307NMR); N/A, N/A (814535MR1); 5107849-2, 00000283624MR5 (615588MRI); N/A, N/A (615473MR1); N/A, N/A (817922MRLX); 5107849-2, 00000278623MR4 (972378NSC3TMR1); 46-294231G1, 0002005-0823-7 (DZ1057MR01); 46-294231G1, 002006-0127-10 (DZ1193MR01); 2226300, 00000000R5456A (2722SIGNA15); 2226300, 000000000R6230 (4291EXC15T); 2226300, 000000000R4601 (MRR4601); 2226300, 000000000R4973 (0910272001); 2226300, 000000000R5899 (0910274027); M3000PT, 00000280570MR3 (0910273001); 46-294231G1, 002005-0511-13 (AZ1003MR01); 46-294231G1, 0000099-0111-2 (110037MR01); 46-294231G1, 002005-0301-06 (2560124); 2226300, 000000000R5054 (BA4073MR01); N/A, 000000000R6295 (2712857); 5308573, 00000290734MR3 (2771768); 2226300, 000000000R6853 (2776713); 5107849-2, 00000284596MR4 (1236631); 2226300, 000000000R5190 (1191369); N/A, N/A (270004); 2189500-3, 00000201911MR5 (22946-1); 46-294231G1, 002005-0301-18 (CATMR01); 46-294231G1, 000005-1212-11 (CRMR01); 2226300, 000000000R5504 (082427310017); 2215261, 00000215559MR6 (082427040057); 2226300, 000000000R5271 (082427040072); N/A, 00000243366MR2 (082427040040); 46-294231G1, 0000003-0315-2 (082427040061); 2226300, 000000000R6344 (082427040074); 5107849-2, 00000289798MR1 (082427100093); 5107849-2, 00000283174MR1 (082427140047); 5107849-2, 00000282831MR7 (082427140046); 5107849-2, 00000283662MR5 (082427210041); 5107849-2, 00000282959MR6 (2697548EXCITE); 2226300, 000000000R5692 (2694100HD); N/A, N/A (CY1028MR01); 2226300, 000000000R4124 (PC0114MR03); 46-294231G1, 000006-0425-19 (HC4719MR02); 5107849, 00000272346MR8 (CC5340MR02); N/A, 0002005-1020-4 (126597MR01); 46-294231G1, 0002005-0511-6 (125390MR01); 46-294231G1, 000091-0919-12 (PSTU02MR01); 2226300, 000000000R5851 (2704833SIGNA); N/A, 000000000R5205 (GF1002MR01); 2226300, 000000000R4942 (24527633818MRI); 46-294231G1, 002005-0519-10 (0828270022IB01); 46-294231G1, 002005-0216-12 (0828270021IB01); N/A, 0000006-0323-2 (HU1099MR01); 5107849-2, 00000284297MR9 (083027062101067); 5107849, 00000267657MR5 (083027826593614); 46-294231G1, 000007-0530-11 (083027592002490); N/A, N/A (083027062101391); 2226300, 000000000R5902 (083027602101557); N/A, N/A (0835270007); 2108800-2, 535779 (B5174306); 46-294231G1, 0002005-0714-6 (A126322002); N/A, N/A (B5183714); 2226300, 000000000R5542 (B5367312); 2377062-2, 00000963588YM9 (A6118004); N/A, N/A (A148761302); N/A, 00000189273MR6 (A5155133); 2226300, 000000000R5739 (A377686701); 2226300, 000000000R5390 (A6134706); 46-294231G1, 002001-0702-56 (A5104397); 2357500-3, 00000300710MR1 (A5739706); 46-294231G1, 002005-0805-20 (YM1503); 2226300, 000000000R4952 (YM1516); 2198999-2, 00000158807MR8 (YM0451); N/A, 000000000R4216 (JO1029MR01); 2226300, 000000000R1382 (0850270404); N/A, 00000271322MR0 (0850270094); 5107849, 00000282503MR2 (LV4038MR01); 46-294231G1, 0002005-1130-3 (1084MREINP); 5107849, 00000263976MR3 (MR262474MR0); 2377062-2, 00000963560YM8 (5606SIGNA); 46-294231G1, 002005-0411-13 (56MRE3TH2565370); 2226300, 000000000R5911 (813EXCITEHD); 2226300, 000000000R5037 (2640781MR-1); 2226300, 000000000R5966 (99251SIGNAHD); 46-294231G1, 000006-0403-14 (99201MR15); 2395001-2, 00000280669MR3 (0920279025); 46-294231G1, 0000099-0722-5 (0920279011); N/A, N/A (25565916MR); 2226300, 00000000R4926A (PL1530MR02); 46-294231G1, 000006-0308-13 (787740MOBILE); 5107849, 00000276591MR5 (787653MR3T); 46-294231G1, 0000006-0315-5 (787840CIRT3T); 46-294231G1, 002001-0530-30 (787840EXCITE); N/A, 000000000R5552 (RO1115MR01); 2226300, 000000000R5057 (RU1195MR01); 46-294231G1, 002005-1212-26 (600130MR02); 5107849, 00000275845MR6 (RU1283MR01); 46-294231G1, 000006-0412-16 (RU1296MR01); 2226300, 000000000R5862 (SA1014MR02); 2226300, 000000000R5545 (SA2051MR01); 2226300, 000000000R5699 (SA1041MR02); 46-294231G1, 002005-0328-20 (SA1004MR02); N/A, 002005-1018-11 (SA1006MR02); 2226300, 000000000R5764 (SA1021MR01); 2226300, 000000000R4655 (0847270017); 46-294231G1, 002005-1201-14 (ZA1180MR01); 2226300, 000000000R5102 (NPV31703); 2226300, 000000000R4415 (MPX33111); 2357500-2, 00000265818MR5 (MPX49302); 5107849, 00000275642MR7 (GEE34040); 2357500-2, 00000265818MR5 (MPX94700); 5107849, 00000278210MR0 (UPW21613); 2377062-2, 00000963343YM9 (DPI53205); 5107849, 00000267036MR2 (DPN62300); 46-294231G1, 0000094-0131-5 (DPM19607); 46-294231G1, 0000005-0209-1 (FPG33602); 5127452, 00000VALUE1177 (NPV77700); N/A, 002005-0627-13 (387040MR06); 2357500, 00000259106MR3 (0853270052IB1); N/A, N/A (0853270070); 46-294231G1, 0002005-0519-8 (0856270035); 2226300, 000000000R4976 (0856270037); N/A, N/A (0856270042); 5107849-2, 00000279892MR4 (06108MRS01); 46-294231G1, 002005-1201-26 (34006MRS03); 46-294231G1, 000006-0502-12 (35045MRS01); 2226300, 00000000R4866A (78004MRS01); N/A, N/A (45007MRS01); 5107849, 00000266746MR7 (54014MRS01); 2226300, 000000000R5885 63025MRS01); 2226300, 000000000R5892 (UK1015MR02); N/A, N/A (00133MRS02); N/A, N/A (05270MRS01); 46-294231G1, 002002-0221-13 (70065MRS02); 5107849-2, 00000280006MR8 (10079MRM73); 46-294231G1, 0000006-0511-7 (3882630908MRMET);
  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, LLC
Reason for Recall:
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E

Product Codes/Lot Numbers:

Model Number, Serial Number (System ID) : 2226300, 000000000R4938 (256329MR2); 2226300, 000000000R5598 (256ALOPMR); N/A, N/A (334699MR); 2377062-2, 00000002547YR8 (256265HMR); 5107849, 00000274691MR5 (205487MR2); 46-294231G1, 0002005-0411-5 (870972E16); 46-294231G1, 002005-1201-35 (623583MR1); 2377062-2, 00000963660YM6 (480323MR1); 5107849-2, 00000278561MR6 (818445MR); 46-294231G1, 002004-1028-04 (3825); 2377062, 00000941225YM5 (626335MR); 46-294231G1, 002004-0913-01 (3591); 46-294231G1, 002005-1018-15 (352333MR3T); N/A, N/A (954587MR1); 46-294231G1, 002002-0605-11 (781340MR); 5107849, 266201MR3 (RADNETMR1585); 46-294231G1, 002005-0110-28 (313593MR02); 5308573, 00000292781MR2 (609890MR); 2214149-2, 00000010224GQ4 (732745MR); 2377062-2, 00000963098YM9 (607798MREXCT); N/A, N/A (516825MR); N/A, N/A (405307NMR); N/A, N/A (814535MR1); 5107849-2, 00000283624MR5 (615588MRI); N/A, N/A (615473MR1); N/A, N/A (817922MRLX); 5107849-2, 00000278623MR4 (972378NSC3TMR1); 46-294231G1, 0002005-0823-7 (DZ1057MR01); 46-294231G1, 002006-0127-10 (DZ1193MR01); 2226300, 00000000R5456A (2722SIGNA15); 2226300, 000000000R6230 (4291EXC15T); 2226300, 000000000R4601 (MRR4601); 2226300, 000000000R4973 (0910272001); 2226300, 000000000R5899 (0910274027); M3000PT, 00000280570MR3 (0910273001); 46-294231G1, 002005-0511-13 (AZ1003MR01); 46-294231G1, 0000099-0111-2 (110037MR01); 46-294231G1, 002005-0301-06 (2560124); 2226300, 000000000R5054 (BA4073MR01); N/A, 000000000R6295 (2712857); 5308573, 00000290734MR3 (2771768); 2226300, 000000000R6853 (2776713); 5107849-2, 00000284596MR4 (1236631); 2226300, 000000000R5190 (1191369); N/A, N/A (270004); 2189500-3, 00000201911MR5 (22946-1); 46-294231G1, 002005-0301-18 (CATMR01); 46-294231G1, 000005-1212-11 (CRMR01); 2226300, 000000000R5504 (082427310017); 2215261, 00000215559MR6 (082427040057); 2226300, 000000000R5271 (082427040072); N/A, 00000243366MR2 (082427040040); 46-294231G1, 0000003-0315-2 (082427040061); 2226300, 000000000R6344 (082427040074); 5107849-2, 00000289798MR1 (082427100093); 5107849-2, 00000283174MR1 (082427140047); 5107849-2, 00000282831MR7 (082427140046); 5107849-2, 00000283662MR5 (082427210041); 5107849-2, 00000282959MR6 (2697548EXCITE); 2226300, 000000000R5692 (2694100HD); N/A, N/A (CY1028MR01); 2226300, 000000000R4124 (PC0114MR03); 46-294231G1, 000006-0425-19 (HC4719MR02); 5107849, 00000272346MR8 (CC5340MR02); N/A, 0002005-1020-4 (126597MR01); 46-294231G1, 0002005-0511-6 (125390MR01); 46-294231G1, 000091-0919-12 (PSTU02MR01); 2226300, 000000000R5851 (2704833SIGNA); N/A, 000000000R5205 (GF1002MR01); 2226300, 000000000R4942 (24527633818MRI); 46-294231G1, 002005-0519-10 (0828270022IB01); 46-294231G1, 002005-0216-12 (0828270021IB01); N/A, 0000006-0323-2 (HU1099MR01); 5107849-2, 00000284297MR9 (083027062101067); 5107849, 00000267657MR5 (083027826593614); 46-294231G1, 000007-0530-11 (083027592002490); N/A, N/A (083027062101391); 2226300, 000000000R5902 (083027602101557); N/A, N/A (0835270007); 2108800-2, 535779 (B5174306); 46-294231G1, 0002005-0714-6 (A126322002); N/A, N/A (B5183714); 2226300, 000000000R5542 (B5367312); 2377062-2, 00000963588YM9 (A6118004); N/A, N/A (A148761302); N/A, 00000189273MR6 (A5155133); 2226300, 000000000R5739 (A377686701); 2226300, 000000000R5390 (A6134706); 46-294231G1, 002001-0702-56 (A5104397); 2357500-3, 00000300710MR1 (A5739706); 46-294231G1, 002005-0805-20 (YM1503); 2226300, 000000000R4952 (YM1516); 2198999-2, 00000158807MR8 (YM0451); N/A, 000000000R4216 (JO1029MR01); 2226300, 000000000R1382 (0850270404); N/A, 00000271322MR0 (0850270094); 5107849, 00000282503MR2 (LV4038MR01); 46-294231G1, 0002005-1130-3 (1084MREINP); 5107849, 00000263976MR3 (MR262474MR0); 2377062-2, 00000963560YM8 (5606SIGNA); 46-294231G1, 002005-0411-13 (56MRE3TH2565370); 2226300, 000000000R5911 (813EXCITEHD); 2226300, 000000000R5037 (2640781MR-1); 2226300, 000000000R5966 (99251SIGNAHD); 46-294231G1, 000006-0403-14 (99201MR15); 2395001-2, 00000280669MR3 (0920279025); 46-294231G1, 0000099-0722-5 (0920279011); N/A, N/A (25565916MR); 2226300, 00000000R4926A (PL1530MR02); 46-294231G1, 000006-0308-13 (787740MOBILE); 5107849, 00000276591MR5 (787653MR3T); 46-294231G1, 0000006-0315-5 (787840CIRT3T); 46-294231G1, 002001-0530-30 (787840EXCITE); N/A, 000000000R5552 (RO1115MR01); 2226300, 000000000R5057 (RU1195MR01); 46-294231G1, 002005-1212-26 (600130MR02); 5107849, 00000275845MR6 (RU1283MR01); 46-294231G1, 000006-0412-16 (RU1296MR01); 2226300, 000000000R5862 (SA1014MR02); 2226300, 000000000R5545 (SA2051MR01); 2226300, 000000000R5699 (SA1041MR02); 46-294231G1, 002005-0328-20 (SA1004MR02); N/A, 002005-1018-11 (SA1006MR02); 2226300, 000000000R5764 (SA1021MR01); 2226300, 000000000R4655 (0847270017); 46-294231G1, 002005-1201-14 (ZA1180MR01); 2226300, 000000000R5102 (NPV31703); 2226300, 000000000R4415 (MPX33111); 2357500-2, 00000265818MR5 (MPX49302); 5107849, 00000275642MR7 (GEE34040); 2357500-2, 00000265818MR5 (MPX94700); 5107849, 00000278210MR0 (UPW21613); 2377062-2, 00000963343YM9 (DPI53205); 5107849, 00000267036MR2 (DPN62300); 46-294231G1, 0000094-0131-5 (DPM19607); 46-294231G1, 0000005-0209-1 (FPG33602); 5127452, 00000VALUE1177 (NPV77700); N/A, 002005-0627-13 (387040MR06); 2357500, 00000259106MR3 (0853270052IB1); N/A, N/A (0853270070); 46-294231G1, 0002005-0519-8 (0856270035); 2226300, 000000000R4976 (0856270037); N/A, N/A (0856270042); 5107849-2, 00000279892MR4 (06108MRS01); 46-294231G1, 002005-1201-26 (34006MRS03); 46-294231G1, 000006-0502-12 (35045MRS01); 2226300, 00000000R4866A (78004MRS01); N/A, N/A (45007MRS01); 5107849, 00000266746MR7 (54014MRS01); 2226300, 000000000R5885 63025MRS01); 2226300, 000000000R5892 (UK1015MR02); N/A, N/A (00133MRS02); N/A, N/A (05270MRS01); 46-294231G1, 002002-0221-13 (70065MRS02); 5107849-2, 00000280006MR8 (10079MRM73); 46-294231G1, 0000006-0511-7 (3882630908MRMET);

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0111-2019

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