🔍 RecallPedia

B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

Class I - Dangerous
🏥 Medical Devices Recalled: November 16, 2022 GE Medical Systems Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00840682147217: Model Number 6160000-001-100174, Serial Numbers: SR422332028WA, SR422332025WA, SR422332026WA, SR422332027WA, SR422332029WA, SR422332030WA, SR422332031WA, SR422332032WA, SR422332049WA, SR422332050WA, SR422332051WA, SR422332052WA, SR422332053WA, SR422332054WA, SR422332055WA, SR422332056WA, SR422332057WA, SR422332061WA, SR422332058WA, SR422332059WA, SR422332060WA, SR422332062WA, SR422332063WA, SR422332064WA, SR422332047WA, SR422332044WA, SR422332045WA, SR422332046WA, SR422332048WA, SR422332033WA, SR422332034WA, SR422332035WA, SR422332036WA, SR422332037WA, SR422332038WA, SR422332039WA, SR422332040WA, SR422332041WA, SR422332042WA, SR422332043WA, SR422332017WA, SR422332018WA, SR422332019WA, SR422332020WA, SR422332021WA, SR422332022WA, SR422332023WA, SR422332024WA, SR422332065WA, SR422332066WA, SR422332067WA, SR422332068WA, SR422332069WA, SR422332070WA, SR422332071WA, SR422332072WA, SR422332081WA, SR422332082WA, SR422332083WA, SR422332084WA, SR422332085WA, SR422332086WA, SR422332087WA, SR422332088WA, SR422332089WA, SR422332090WA, SR422332094WA, SR422332091WA, SR422332092WA, SR422332093WA, SR422332096WA, SR422332095WA, SR422332113WA, SR422332114WA, SR422332115WA, SR422332116WA, SR422332117WA, SR422332118WA, SR422332119WA, SR422332120WA, SR422332121WA, SR422332122WA, SR422332123WA, SR422332127WA, SR422332129WA, SR422332135WA, SR422332136WA, SR422332137WA, SR422332001WA, SR422332002WA, SR422332003WA, SR422332004WA, SR422332005WA, SR422332006WA, SR422332007WA, SR422332008WA, SR422332009WA, SR422332010WA, SR422332011WA, SR422332015WA, SR422332012WA, SR422332013WA, SR422332014WA, SR422332016WA, SR422332073WA, SR422332077WA, SR422332074WA, SR422332075WA, SR422332076WA, SR422332078WA, SR422332079WA, SR422332080WA, SR422332097WA, SR422332098WA, SR422332099WA, SR422332100WA, SR422332101WA, SR422332102WA, SR422332103WA, SR422332104WA, SR422332105WA, SR422332106WA, SR422332107WA, SR422332108WA, SR422332109WA, SR422332110WA, SR422332111WA, SR422332112WA, SR422332177WA, SR422332174WA, SR422332175WA, SR422332176WA, SR422332178WA, SR422332179WA, SR422332180WA, SR422332181WA, SR422332182WA, SR422332183WA, SR422332184WA, SR422332185WA, SR422332186WA, SR422332187WA, SR422332188WA, SR422332192WA, SR422332189WA, SR422332190WA, SR422332191WA, SR422332193WA, SR422332194WA, SR422332195WA, SR422332196WA, SR422332197WA, SR422332198WA, SR422332199WA, SR422332200WA, SR422332201WA, SR422332202WA, SR422332203WA, SR422332204WA, SR422332205WA, SR422332206WA, SR422332207WA, SR422332208WA, SR422332210WA, SR422332209WA, SR422332211WA, SR422332212WA, SR422332213WA, SR422332214WA, SR422332215WA, SR422332216WA, SR422332217WA, SR422332218WA, SR422332219WA, SR422332220WA, SR422332221WA, SR422332222WA, SR422332223WA, SR422332224WA, SR422332225WA, SR422332226WA, SR422332227WA, SR422332228WA, SR422332229WA, SR422332230WA, SR422332251WA, SR422332252WA, SR422332253WA, SR422332254WA, SR422332255WA, SR422332256WA, SR422332257WA, SR422332258WA, SR422332259WA, SR422332263WA, SR422332260WA, SR422332261WA, SR422332262WA, SR422332128WA, SR422332124WA, SR422332125WA, SR422332126WA, SR422332130WA, SR422332131WA, SR422332132WA, SR422332133WA, SR422332134WA, SR422332138WA, SR422332267WA, SR422332264WA, SR422332265WA, SR422332266WA, SR422332268WA, SR422332269WA, SR422332270WA, SR422332271WA, SR422332272WA, SR422332273WA, SR422332274WA, SR422332142WA, SR422332139WA, SR422332140WA, SR422332141WA, SR422332143WA, SR422332144WA, SR422332145WA, SR422332149WA, SR422332146WA, SR422332147WA, SR422332148WA, SR422332150WA, SR422332151WA, SR422332152WA, SR422332153WA, SR422332154WA, SR422332155WA, SR422332156WA, SR422332157WA, SR422332158WA, SR422332159WA, SR422332160WA, SR422332161WA, SR422332162WA, SR422332163WA, SR422332164WA, SR422332165WA, SR422332166WA, SR422332167WA, SR422332168WA, SR422332169WA, SR422332170WA, SR422332171WA, SR422332172WA, SR422332173WA; Model Number 6160000-001-100728, Serial Numbers: SR422231017PA, SR422231019PA, SR422231020PA, SR422231021PA, SR422231023PA, SR422241005PA, SR422241002PA, SR422231038PA, SR422241001PA, SR422241003PA, SR422241004PA, SR422231018PA, SR422231028PA, SR422231024PA, SR422231025PA, SR422231027PA, SR422231029PA, SR422231035PA, SR422231036PA, SR422231014PA, SR422231012PA, SR422231013PA, SR422231015PA, SR422231016PA, SR422231033PA, SR422231037PA, SR422231032PA, SR422231034PA, SR422231030PA, SR422231031PA, SR422231026PA, SR422231011PA, SR422231010PA, SR422231009PA, SR422231005PA, SR422231007PA, SR422231008PA, SR422231006PA; Model Number 6160000-001-726232, Serial Numbers: SR420510001WA; Model Number 6160000-001-726248, Serial Numbers: SR420510002WA; Model Number 6160000-001-737890, Serial Numbers: SR421040002WA, SR421050008WA, SR421050009WA, SR421060001WA, SR421060003WA, SR421070001WA, SR421060004WA, SR421050005WA, SR421050006WA, SR421050007WA, SR421060002WA; Model Number 6160000-001-765412, Serial Numbers: SR421100001WA; Model Number 6160000-001-767955, Serial Numbers: SR421070002WA; Model Number 6160000-001-771434, Serial Numbers: SR421120092WA, SR421120089WA, SR421120090WA, SR421120091WA, SR421120093WA, SR421120094WA, SR421120095WA, SR421120096WA, SR421120097WA, SR421120098WA, SR421120099WA, SR421120100WA, SR421120101WA, SR421120102WA, SR421120103WA; Model Number 6160000-001-787700, Serial Numbers: SR421300005WA, SR421150017WA, SR421150014WA, SR421150016WA, SR421250062WA, SR421250059WA, SR421250060WA, SR421250061WA, SR421250063WA, SR421250064WA, SR421250065WA, SR421250066WA, SR421250067WA, SR421250068WA, SR421250069WA, SR421430007WA, SR421430008WA, SR421430006WA, SR421430005WA, SR421440002WA, SR421440001WA, SR421150012WA, SR421150010WA, SR421150011WA, SR421150005WA, SR421150006WA, SR421150007WA, SR421150008WA, SR421150009WA, SR421472004WA, SR421472009WA, SR421472010WA, SR421472001WA, SR421472003WA, SR421472005WA, SR421472006WA, SR421472007WA, SR421472008WA, SR421390019WA, SR421390021WA, SR422152004WA, SR422152001WA, SR422152002WA, SR422152003WA, SR422152005WA, SR422152006WA, SR422152007WA, SR422152008WA, SR422152009WA, SR422152010WA, SR422152011WA, SR422152012WA, SR422152013WA, SR422152015WA, SR422152014WA, SR421430009WA, SR421452037WA, SR421452038WA, SR421502010WA, SR421502007WA, SR421502008WA, SR421502009WA, SR421502011WA, SR421502012WA, SR421502057WA, SR421502054WA, SR421502055WA, SR421502056WA, SR421502058WA, SR421502059WA, SR421502060WA, SR421502061WA, SR421502062WA, SR421502063WA, SR421502064WA, SR421502065WA, SR421502066WA, SR421502069WA, SR421502068WA, SR421150015WA, SR421300004WA, SR421300003WA, SR421300006WA, SR421390020WA, SR421390017WA, SR421390018WA, SR421502067WA, SR421472002WA, SR421170045WA, SR421482043WA; Model Number 6160000-001-788679, Serial Numbers: SR421130122WA, SR421130120WA, SR421130121WA, SR421130123WA, SR421130124WA, SR421130125WA, SR421130126WA, SR421130127WA, SR421130128WA, SR421130129WA, SR421130130WA, SR421130131WA, SR421130132WA, SR421130133WA, SR421160001WA, SR421160026WA, SR421200053WA, SR421482020WA, SR421482021WA, SR421482022WA, SR421482023WA, SR421482024WA, SR421482025WA, SR421482026WA, SR421482027WA, SR421130112WA, SR422032010WA, SR421130113WA, SR421130115WA, SR421160053WA, SR421160050WA, SR421160051WA, SR421160052WA, SR421160045WA, SR421160046WA, SR421160047WA, SR421160048WA, SR421160049WA, SR421410057WA, SR421482038WA, SR421482039WA, SR421482040WA, SR421482041WA, SR421482042WA, SR421260007WA, SR421260008WA, SR421260009WA, SR421410062WA, SR421260038WA, SR421260037WA, SR421260039WA, SR421260040WA, SR421260041WA, SR421260042WA, SR421260043WA, SR421260044WA, SR421260045WA, SR421260046WA, SR421260047WA, SR421260048WA, SR421370076WA, SR421370086WA, SR421410061WA, SR421420081WA, SR421130111WA, SR421420078WA, SR421420077WA, SR421160044WA, SR421160041WA, SR421160042WA, SR421160043WA, SR421160039WA, SR421160037WA, SR421160038WA, SR421160040WA, SR421410051WA, SR421200004WA, SR421200005WA, SR421200006WA, SR421420065WA, SR422032011WA, SR421260006WA, SR421160004WA, SR421160002WA, SR421160005WA, SR421160006WA, SR421260010WA, SR421260011WA, SR421260013WA, SR421260014WA, SR421420066WA, SR421420070WA, SR421420071WA, SR421420072WA, SR421420073WA, SR421420074WA, SR421420075WA, SR421420076WA, SR422032007WA, SR422032005WA, SR422032006WA, SR422032008WA, SR421370078WA, SR421420067WA, SR421420068WA, SR421420079WA, SR421420069WA, SR421160003WA, SR421260003WA, SR421260004WA, SR421370065WA, SR421370063WA, SR421370064WA, SR421370066WA, SR421370067WA, SR421370068WA, SR421370069WA, SR421370070WA, SR421370071WA, SR421370072WA, SR421370079WA, SR421370080WA, SR421370084WA, SR421370081WA, SR421370082WA, SR421370083WA, SR421420082WA, SR421420083WA, SR421420084WA, SR421420085WA, SR421482018WA, SR421482019WA, SR421260012WA, SR421160032WA, SR421160034WA, SR421160035WA, SR421160036WA, SR421160033WA, SR422032004WA, SR421260035WA, SR421260036WA, SR421260032WA, SR421260033WA, SR421260034WA, SR421200042WA, SR421200043WA, SR421200044WA, SR421200045WA, SR421200046WA, SR421200047WA, SR421200051WA, SR421200048WA, SR421200049WA, SR421200050WA, SR421482033WA, SR421482032WA, SR421482034WA, SR421482035WA, SR421482036WA, SR421482037WA, SR421200052WA, SR421160012WA, SR421160013WA, SR421160014WA, SR421370085WA, SR421130109WA, SR421130110WA, SR421160031WA, SR421160028WA, SR421160029WA, SR421160030WA, SR421160027WA, SR421200007WA, SR421200008WA, SR421200009WA, SR421200010WA, SR421200011WA, SR421200012WA, SR421200013WA, SR421200014WA, SR421200015WA, SR421200016WA, SR421200017WA, SR421200018WA, SR421200019WA, SR421200020WA, SR421200021WA, SR421200022WA, SR421200023WA, SR421200027WA, SR421200024WA, SR421200025WA, SR421200026WA, SR421200028WA, SR421200029WA, SR421200033WA, SR421200030WA, SR421200031WA, SR421200032WA, SR421200037WA, SR421200034WA, SR421200035WA, SR421200036WA, SR421200038WA, SR421200039WA, SR421200040WA, SR421200041WA, SR421420064WA, SR421410053WA, SR421120059WA, SR421120056WA, SR421120057WA, SR421120058WA, SR421120060WA, SR421120061WA, SR421120062WA, SR421120063WA, SR421120064WA, SR421120065WA, SR421120066WA, SR421120067WA, SR421120068WA, SR421120069WA, SR421120070WA, SR421120071WA, SR421120072WA, SR421130106WA, SR421120073WA, SR421130104WA, SR421130105WA, SR421130107WA, SR421130108WA, SR421120054WA, SR421120055WA, SR421160054WA, SR421160055WA, SR421410054WA, SR421370075WA, SR421130117WA, SR421410055WA, SR421410056WA, SR421130118WA, SR421260049WA, SR421260050WA, SR421260051WA, SR421260052WA, SR421410059WA, SR421130119WA, SR421410060WA, SR421160015WA, SR421160016WA, SR421160017WA, SR421160023WA, SR421160024WA, SR421160025WA, SR421370077WA, SR421370062WA, SR421260015WA, SR421482029WA, SR421482030WA, SR421482031WA, SR421370073WA, SR421370074WA, SR421420080WA, SR421160007WA, SR421160008WA, SR421160009WA, SR421160010WA, SR421160011WA, SR421260005WA, SR421410052WA, SR422032012WA, SR422032013WA, SR422032014WA, SR422032015WA, SR422032016WA, SR422032017WA, SR422032018WA, SR422032022WA, SR422032019WA, SR422032020WA, SR422032021WA, SR422032026WA, SR422032023WA, SR422032024WA, SR422032025WA, SR422032027WA, SR422032028WA, SR421130114WA, SR421410058WA, SR421482028WA, SR421410063WA, SR422032009WA, SR421130116WA, SR421260024WA, SR421260025WA, SR421260026WA, SR421260027WA, SR421260028WA, SR421260016WA, SR421260017WA, SR421260018WA, SR421260019WA, SR421260020WA, SR421260021WA, SR421260022WA, SR421260023WA, SR421260029WA, SR421260030WA, SR421260031WA; Model Number 6160000-001-791943, Serial Numbers: SR421240058WA, SR421160018WA, SR421160020WA, SR421160019WA; Model Number 6160000-001-794786, Serial Numbers: SR421230004WA, SR421230001WA, SR421230002WA, SR421230003WA, SR421230005WA, SR421230006WA, SR421230007WA, SR421230008WA, SR421230009WA, SR421230010WA, SR421230011WA, SR421230012WA, SR421230013WA, SR421230014WA, SR421230015WA, SR421230016WA, SR421230017WA, SR421230018WA, SR421230019WA, SR421230020WA, SR421250058WA, SR421250057WA, SR421250051WA; Model Number 6160000-001-799233, Serial Numbers: SR421150001WA; Model Number 6160000-001-802266, Serial Numbers: SR421220010WA, SR421220011WA, SR421472093WA, SR421472094WA; Model Number 6160000-001-803246, Serial Numbers: SR421160022WA; Model Number 6160000-001-830726, Serial Numbers: SR421260060WA, SR421260061WA, SR421260062WA, SR421260063WA; Model Number 6160000-001-839141, Serial Numbers: SR421260002WA; Model Number 6160000-001-848493, Serial Numbers: SR421280010WA; Model Number 6160000-001-848921, Serial Numbers: SR421280007WA, SR421280008WA, SR421280009WA; Model Number 6160000-001-861261, Serial Numbers: SR421380006WA, SR421380007WA; Model Number 6160000-001-906100, Serial Numbers: SR421440015WA, SR421440016WA, SR421452002WA, SR421452003WA, SR421452004WA, SR421452005WA, SR421452006WA, SR421452007WA, SR421452009WA, SR421452010WA, SR421452011WA, SR421452012WA, SR421452014WA, SR421452015WA, SR421452016WA, SR421440007WA, SR421440008WA, SR421440009WA, SR421440010WA, SR421440011WA, SR421440012WA, SR421440013WA, SR421440014WA, SR421452001WA, SR421452008WA, SR421452013WA; Model Number 6160000-001-906386, Serial Numbers: SR421472011WA; Model Number 6160000-001-925411, Serial Numbers: SR422352045WA; Model Number 6160000-001-928665, Serial Numbers: SR421472013WA, SR421472012WA; Model Number 6160000-001-954478, Serial Numbers: SR422112038WA, SR422112035WA, SR422112036WA, SR422112037WA, SR422112039WA, SR422112040WA, SR422112041WA, SR422112042WA, SR422112043WA, SR422112044WA, SR422382004WA, SR422382005WA, SR422382006WA, SR422382007WA, SR422382008WA, SR422382009WA, SR422382010WA, SR422382011WA, SR422382012WA, SR422382013WA, SR422382014WA, SR422382015WA, SR422382016WA, SR422382017WA, SR422382018WA, SR422382019WA, SR422382020WA, SR422382003WA, SR422382001WA, SR422382002WA.
  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:
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

Product Codes/Lot Numbers:

UDI/DI 00840682147217: Model Number 6160000-001-100174, Serial Numbers: SR422332028WA, SR422332025WA, SR422332026WA, SR422332027WA, SR422332029WA, SR422332030WA, SR422332031WA, SR422332032WA, SR422332049WA, SR422332050WA, SR422332051WA, SR422332052WA, SR422332053WA, SR422332054WA, SR422332055WA, SR422332056WA, SR422332057WA, SR422332061WA, SR422332058WA, SR422332059WA, SR422332060WA, SR422332062WA, SR422332063WA, SR422332064WA, SR422332047WA, SR422332044WA, SR422332045WA, SR422332046WA, SR422332048WA, SR422332033WA, SR422332034WA, SR422332035WA, SR422332036WA, SR422332037WA, SR422332038WA, SR422332039WA, SR422332040WA, SR422332041WA, SR422332042WA, SR422332043WA, SR422332017WA, SR422332018WA, SR422332019WA, SR422332020WA, SR422332021WA, SR422332022WA, SR422332023WA, SR422332024WA, SR422332065WA, SR422332066WA, SR422332067WA, SR422332068WA, SR422332069WA, SR422332070WA, SR422332071WA, SR422332072WA, SR422332081WA, SR422332082WA, SR422332083WA, SR422332084WA, SR422332085WA, SR422332086WA, SR422332087WA, SR422332088WA, SR422332089WA, SR422332090WA, SR422332094WA, SR422332091WA, SR422332092WA, SR422332093WA, SR422332096WA, SR422332095WA, SR422332113WA, SR422332114WA, SR422332115WA, SR422332116WA, SR422332117WA, SR422332118WA, SR422332119WA, SR422332120WA, SR422332121WA, SR422332122WA, SR422332123WA, SR422332127WA, SR422332129WA, SR422332135WA, SR422332136WA, SR422332137WA, SR422332001WA, SR422332002WA, SR422332003WA, SR422332004WA, SR422332005WA, SR422332006WA, SR422332007WA, SR422332008WA, SR422332009WA, SR422332010WA, SR422332011WA, SR422332015WA, SR422332012WA, SR422332013WA, SR422332014WA, SR422332016WA, SR422332073WA, SR422332077WA, SR422332074WA, SR422332075WA, SR422332076WA, SR422332078WA, SR422332079WA, SR422332080WA, SR422332097WA, SR422332098WA, SR422332099WA, SR422332100WA, SR422332101WA, SR422332102WA, SR422332103WA, SR422332104WA, SR422332105WA, SR422332106WA, SR422332107WA, SR422332108WA, SR422332109WA, SR422332110WA, SR422332111WA, SR422332112WA, SR422332177WA, SR422332174WA, SR422332175WA, SR422332176WA, SR422332178WA, SR422332179WA, SR422332180WA, SR422332181WA, SR422332182WA, SR422332183WA, SR422332184WA, SR422332185WA, SR422332186WA, SR422332187WA, SR422332188WA, SR422332192WA, SR422332189WA, SR422332190WA, SR422332191WA, SR422332193WA, SR422332194WA, SR422332195WA, SR422332196WA, SR422332197WA, SR422332198WA, SR422332199WA, SR422332200WA, SR422332201WA, SR422332202WA, SR422332203WA, SR422332204WA, SR422332205WA, SR422332206WA, SR422332207WA, SR422332208WA, SR422332210WA, SR422332209WA, SR422332211WA, SR422332212WA, SR422332213WA, SR422332214WA, SR422332215WA, SR422332216WA, SR422332217WA, SR422332218WA, SR422332219WA, SR422332220WA, SR422332221WA, SR422332222WA, SR422332223WA, SR422332224WA, SR422332225WA, SR422332226WA, SR422332227WA, SR422332228WA, SR422332229WA, SR422332230WA, SR422332251WA, SR422332252WA, SR422332253WA, SR422332254WA, SR422332255WA, SR422332256WA, SR422332257WA, SR422332258WA, SR422332259WA, SR422332263WA, SR422332260WA, SR422332261WA, SR422332262WA, SR422332128WA, SR422332124WA, SR422332125WA, SR422332126WA, SR422332130WA, SR422332131WA, SR422332132WA, SR422332133WA, SR422332134WA, SR422332138WA, SR422332267WA, SR422332264WA, SR422332265WA, SR422332266WA, SR422332268WA, SR422332269WA, SR422332270WA, SR422332271WA, SR422332272WA, SR422332273WA, SR422332274WA, SR422332142WA, SR422332139WA, SR422332140WA, SR422332141WA, SR422332143WA, SR422332144WA, SR422332145WA, SR422332149WA, SR422332146WA, SR422332147WA, SR422332148WA, SR422332150WA, SR422332151WA, SR422332152WA, SR422332153WA, SR422332154WA, SR422332155WA, SR422332156WA, SR422332157WA, SR422332158WA, SR422332159WA, SR422332160WA, SR422332161WA, SR422332162WA, SR422332163WA, SR422332164WA, SR422332165WA, SR422332166WA, SR422332167WA, SR422332168WA, SR422332169WA, SR422332170WA, SR422332171WA, SR422332172WA, SR422332173WA; Model Number 6160000-001-100728, Serial Numbers: SR422231017PA, SR422231019PA, SR422231020PA, SR422231021PA, SR422231023PA, SR422241005PA, SR422241002PA, SR422231038PA, SR422241001PA, SR422241003PA, SR422241004PA, SR422231018PA, SR422231028PA, SR422231024PA, SR422231025PA, SR422231027PA, SR422231029PA, SR422231035PA, SR422231036PA, SR422231014PA, SR422231012PA, SR422231013PA, SR422231015PA, SR422231016PA, SR422231033PA, SR422231037PA, SR422231032PA, SR422231034PA, SR422231030PA, SR422231031PA, SR422231026PA, SR422231011PA, SR422231010PA, SR422231009PA, SR422231005PA, SR422231007PA, SR422231008PA, SR422231006PA; Model Number 6160000-001-726232, Serial Numbers: SR420510001WA; Model Number 6160000-001-726248, Serial Numbers: SR420510002WA; Model Number 6160000-001-737890, Serial Numbers: SR421040002WA, SR421050008WA, SR421050009WA, SR421060001WA, SR421060003WA, SR421070001WA, SR421060004WA, SR421050005WA, SR421050006WA, SR421050007WA, SR421060002WA; Model Number 6160000-001-765412, Serial Numbers: SR421100001WA; Model Number 6160000-001-767955, Serial Numbers: SR421070002WA; Model Number 6160000-001-771434, Serial Numbers: SR421120092WA, SR421120089WA, SR421120090WA, SR421120091WA, SR421120093WA, SR421120094WA, SR421120095WA, SR421120096WA, SR421120097WA, SR421120098WA, SR421120099WA, SR421120100WA, SR421120101WA, SR421120102WA, SR421120103WA; Model Number 6160000-001-787700, Serial Numbers: SR421300005WA, SR421150017WA, SR421150014WA, SR421150016WA, SR421250062WA, SR421250059WA, SR421250060WA, SR421250061WA, SR421250063WA, SR421250064WA, SR421250065WA, SR421250066WA, SR421250067WA, SR421250068WA, SR421250069WA, SR421430007WA, SR421430008WA, SR421430006WA, SR421430005WA, SR421440002WA, SR421440001WA, SR421150012WA, SR421150010WA, SR421150011WA, SR421150005WA, SR421150006WA, SR421150007WA, SR421150008WA, SR421150009WA, SR421472004WA, SR421472009WA, SR421472010WA, SR421472001WA, SR421472003WA, SR421472005WA, SR421472006WA, SR421472007WA, SR421472008WA, SR421390019WA, SR421390021WA, SR422152004WA, SR422152001WA, SR422152002WA, SR422152003WA, SR422152005WA, SR422152006WA, SR422152007WA, SR422152008WA, SR422152009WA, SR422152010WA, SR422152011WA, SR422152012WA, SR422152013WA, SR422152015WA, SR422152014WA, SR421430009WA, SR421452037WA, SR421452038WA, SR421502010WA, SR421502007WA, SR421502008WA, SR421502009WA, SR421502011WA, SR421502012WA, SR421502057WA, SR421502054WA, SR421502055WA, SR421502056WA, SR421502058WA, SR421502059WA, SR421502060WA, SR421502061WA, SR421502062WA, SR421502063WA, SR421502064WA, SR421502065WA, SR421502066WA, SR421502069WA, SR421502068WA, SR421150015WA, SR421300004WA, SR421300003WA, SR421300006WA, SR421390020WA, SR421390017WA, SR421390018WA, SR421502067WA, SR421472002WA, SR421170045WA, SR421482043WA; Model Number 6160000-001-788679, Serial Numbers: SR421130122WA, SR421130120WA, SR421130121WA, SR421130123WA, SR421130124WA, SR421130125WA, SR421130126WA, SR421130127WA, SR421130128WA, SR421130129WA, SR421130130WA, SR421130131WA, SR421130132WA, SR421130133WA, SR421160001WA, SR421160026WA, SR421200053WA, SR421482020WA, SR421482021WA, SR421482022WA, SR421482023WA, SR421482024WA, SR421482025WA, SR421482026WA, SR421482027WA, SR421130112WA, SR422032010WA, SR421130113WA, SR421130115WA, SR421160053WA, SR421160050WA, SR421160051WA, SR421160052WA, SR421160045WA, SR421160046WA, SR421160047WA, SR421160048WA, SR421160049WA, SR421410057WA, SR421482038WA, SR421482039WA, SR421482040WA, SR421482041WA, SR421482042WA, SR421260007WA, SR421260008WA, SR421260009WA, SR421410062WA, SR421260038WA, SR421260037WA, SR421260039WA, SR421260040WA, SR421260041WA, SR421260042WA, SR421260043WA, SR421260044WA, SR421260045WA, SR421260046WA, SR421260047WA, SR421260048WA, SR421370076WA, SR421370086WA, SR421410061WA, SR421420081WA, SR421130111WA, SR421420078WA, SR421420077WA, SR421160044WA, SR421160041WA, SR421160042WA, SR421160043WA, SR421160039WA, SR421160037WA, SR421160038WA, SR421160040WA, SR421410051WA, SR421200004WA, SR421200005WA, SR421200006WA, SR421420065WA, SR422032011WA, SR421260006WA, SR421160004WA, SR421160002WA, SR421160005WA, SR421160006WA, SR421260010WA, SR421260011WA, SR421260013WA, SR421260014WA, SR421420066WA, SR421420070WA, SR421420071WA, SR421420072WA, SR421420073WA, SR421420074WA, SR421420075WA, SR421420076WA, SR422032007WA, SR422032005WA, SR422032006WA, SR422032008WA, SR421370078WA, SR421420067WA, SR421420068WA, SR421420079WA, SR421420069WA, SR421160003WA, SR421260003WA, SR421260004WA, SR421370065WA, SR421370063WA, SR421370064WA, SR421370066WA, SR421370067WA, SR421370068WA, SR421370069WA, SR421370070WA, SR421370071WA, SR421370072WA, SR421370079WA, SR421370080WA, SR421370084WA, SR421370081WA, SR421370082WA, SR421370083WA, SR421420082WA, SR421420083WA, SR421420084WA, SR421420085WA, SR421482018WA, SR421482019WA, SR421260012WA, SR421160032WA, SR421160034WA, SR421160035WA, SR421160036WA, SR421160033WA, SR422032004WA, SR421260035WA, SR421260036WA, SR421260032WA, SR421260033WA, SR421260034WA, SR421200042WA, SR421200043WA, SR421200044WA, SR421200045WA, SR421200046WA, SR421200047WA, SR421200051WA, SR421200048WA, SR421200049WA, SR421200050WA, SR421482033WA, SR421482032WA, SR421482034WA, SR421482035WA, SR421482036WA, SR421482037WA, SR421200052WA, SR421160012WA, SR421160013WA, SR421160014WA, SR421370085WA, SR421130109WA, SR421130110WA, SR421160031WA, SR421160028WA, SR421160029WA, SR421160030WA, SR421160027WA, SR421200007WA, SR421200008WA, SR421200009WA, SR421200010WA, SR421200011WA, SR421200012WA, SR421200013WA, SR421200014WA, SR421200015WA, SR421200016WA, SR421200017WA, SR421200018WA, SR421200019WA, SR421200020WA, SR421200021WA, SR421200022WA, SR421200023WA, SR421200027WA, SR421200024WA, SR421200025WA, SR421200026WA, SR421200028WA, SR421200029WA, SR421200033WA, SR421200030WA, SR421200031WA, SR421200032WA, SR421200037WA, SR421200034WA, SR421200035WA, SR421200036WA, SR421200038WA, SR421200039WA, SR421200040WA, SR421200041WA, SR421420064WA, SR421410053WA, SR421120059WA, SR421120056WA, SR421120057WA, SR421120058WA, SR421120060WA, SR421120061WA, SR421120062WA, SR421120063WA, SR421120064WA, SR421120065WA, SR421120066WA, SR421120067WA, SR421120068WA, SR421120069WA, SR421120070WA, SR421120071WA, SR421120072WA, SR421130106WA, SR421120073WA, SR421130104WA, SR421130105WA, SR421130107WA, SR421130108WA, SR421120054WA, SR421120055WA, SR421160054WA, SR421160055WA, SR421410054WA, SR421370075WA, SR421130117WA, SR421410055WA, SR421410056WA, SR421130118WA, SR421260049WA, SR421260050WA, SR421260051WA, SR421260052WA, SR421410059WA, SR421130119WA, SR421410060WA, SR421160015WA, SR421160016WA, SR421160017WA, SR421160023WA, SR421160024WA, SR421160025WA, SR421370077WA, SR421370062WA, SR421260015WA, SR421482029WA, SR421482030WA, SR421482031WA, SR421370073WA, SR421370074WA, SR421420080WA, SR421160007WA, SR421160008WA, SR421160009WA, SR421160010WA, SR421160011WA, SR421260005WA, SR421410052WA, SR422032012WA, SR422032013WA, SR422032014WA, SR422032015WA, SR422032016WA, SR422032017WA, SR422032018WA, SR422032022WA, SR422032019WA, SR422032020WA, SR422032021WA, SR422032026WA, SR422032023WA, SR422032024WA, SR422032025WA, SR422032027WA, SR422032028WA, SR421130114WA, SR421410058WA, SR421482028WA, SR421410063WA, SR422032009WA, SR421130116WA, SR421260024WA, SR421260025WA, SR421260026WA, SR421260027WA, SR421260028WA, SR421260016WA, SR421260017WA, SR421260018WA, SR421260019WA, SR421260020WA, SR421260021WA, SR421260022WA, SR421260023WA, SR421260029WA, SR421260030WA, SR421260031WA; Model Number 6160000-001-791943, Serial Numbers: SR421240058WA, SR421160018WA, SR421160020WA, SR421160019WA; Model Number 6160000-001-794786, Serial Numbers: SR421230004WA, SR421230001WA, SR421230002WA, SR421230003WA, SR421230005WA, SR421230006WA, SR421230007WA, SR421230008WA, SR421230009WA, SR421230010WA, SR421230011WA, SR421230012WA, SR421230013WA, SR421230014WA, SR421230015WA, SR421230016WA, SR421230017WA, SR421230018WA, SR421230019WA, SR421230020WA, SR421250058WA, SR421250057WA, SR421250051WA; Model Number 6160000-001-799233, Serial Numbers: SR421150001WA; Model Number 6160000-001-802266, Serial Numbers: SR421220010WA, SR421220011WA, SR421472093WA, SR421472094WA; Model Number 6160000-001-803246, Serial Numbers: SR421160022WA; Model Number 6160000-001-830726, Serial Numbers: SR421260060WA, SR421260061WA, SR421260062WA, SR421260063WA; Model Number 6160000-001-839141, Serial Numbers: SR421260002WA; Model Number 6160000-001-848493, Serial Numbers: SR421280010WA; Model Number 6160000-001-848921, Serial Numbers: SR421280007WA, SR421280008WA, SR421280009WA; Model Number 6160000-001-861261, Serial Numbers: SR421380006WA, SR421380007WA; Model Number 6160000-001-906100, Serial Numbers: SR421440015WA, SR421440016WA, SR421452002WA, SR421452003WA, SR421452004WA, SR421452005WA, SR421452006WA, SR421452007WA, SR421452009WA, SR421452010WA, SR421452011WA, SR421452012WA, SR421452014WA, SR421452015WA, SR421452016WA, SR421440007WA, SR421440008WA, SR421440009WA, SR421440010WA, SR421440011WA, SR421440012WA, SR421440013WA, SR421440014WA, SR421452001WA, SR421452008WA, SR421452013WA; Model Number 6160000-001-906386, Serial Numbers: SR421472011WA; Model Number 6160000-001-925411, Serial Numbers: SR422352045WA; Model Number 6160000-001-928665, Serial Numbers: SR421472013WA, SR421472012WA; Model Number 6160000-001-954478, Serial Numbers: SR422112038WA, SR422112035WA, SR422112036WA, SR422112037WA, SR422112039WA, SR422112040WA, SR422112041WA, SR422112042WA, SR422112043WA, SR422112044WA, SR422382004WA, SR422382005WA, SR422382006WA, SR422382007WA, SR422382008WA, SR422382009WA, SR422382010WA, SR422382011WA, SR422382012WA, SR422382013WA, SR422382014WA, SR422382015WA, SR422382016WA, SR422382017WA, SR422382018WA, SR422382019WA, SR422382020WA, SR422382003WA, SR422382001WA, SR422382002WA.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0729-2023

Related Recalls

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

GE Medical Systems

Class I - Dangerous

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

Aug 22, 2025 Other Medical Devices Nationwide View Details →