Z-0733-2023 Class II Ongoing
FDA device recall Z-0733-2023 was initiated by GE Medical Systems, LLC on Nov 16, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 3348 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2022
- Initiation Date
- Nov 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3348 units
Product Description
B125M Patient Monitor, REF 6160000-005-XXXXXXX
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 00840682146791: Model Number 6160000-005, Serial Numbers: SR821512013WA, SR821512014WA, SR821512017WA, SR821512016WA, SR821512015WA, SR821430047WA, SR821430049WA, SR821430048WA, SR821430050WA, SR821410068WA, SR821170021WA, SR822062011WA, SR821260059WA, SR822072018WA, SR822072016WA, SR822072015WA, SR822072022WA, SR822072021WA, SR822072020WA, SR822072019WA, SR822072017WA, SR822072014WA, SR822072013WA, SR821170023WA, SR821180036WA, SR821180037WA, SR821180035WA, SR821180038WA, SR821180039WA, SR821210003WA, SR821210001WA, SR821210002WA, SR821210004WA, SR821210005WA, SR821210006WA, SR821210007WA, SR821210008WA, SR821210009WA, SR821210010WA, SR821250021WA, SR821250027WA, SR821250022WA, SR821250023WA, SR821250024WA, SR821250025WA, SR821260010WA, SR822072012WA, SR822072011WA, SR822072003WA, SR822072005WA, SR822072010WA, SR822072006WA, SR822072009WA, SR822072008WA, SR822072007WA, SR822072004WA, SR821260012WA, SR822062004WA, SR822062005WA, SR822062006WA, SR822290015SA, SR822300010SA, SR822300002SA, SR822300005SA, SR822300007SA, SR822300008SA, SR822300004SA, SR822290019SA, SR822300006SA, SR822290012SA, SR822300001SA, SR822300009SA, SR822290017SA, SR822290018SA, SR822300003SA, SR821170005WA, SR821170020WA, SR821170017WA, SR821170018WA, SR821170019WA, SR821170006WA, SR821410025WA, SR821410001WA, SR821410023WA, SR821410024WA, SR822062010WA, SR821170030WA, SR821170029WA, SR821260056WA, SR821260066WA, SR821260065WA, SR821260064WA, SR821260060WA, SR821260058WA, SR821170033WA, SR821170034WA, SR821260061WA, SR821260063WA, SR821260057WA, SR821260067WA, SR821260001WA, SR821260047WA, SR821260005WA, SR821260069WA, SR821260002WA, SR821260046WA, SR821260049WA, SR821260003WA, SR821260051WA, SR821260068WA, SR821260004WA, SR821260006WA, SR821260052WA, SR821260050WA, SR821410022WA, SR821410021WA, SR821410020WA, SR821410018WA, SR821410017WA, SR821410019WA, SR821350118WA, SR821260018WA, SR821260016WA, SR821260015WA, SR821350119WA, SR821350209WA, SR821350214WA, SR821350117WA, SR821390095WA, SR821260022WA, SR821260020WA, SR821350210WA, SR821350212WA, SR821260019WA, SR821350220WA, SR821350211WA, SR821390093WA, SR821260017WA, SR821350219WA, SR821350115WA, SR821350114WA, SR821390091WA, SR821390089WA, SR821260021WA, SR821260014WA, SR821260026WA, SR821260025WA, SR821260024WA, SR821260023WA, SR821260009WA, SR821260008WA, SR821260011WA, SR821260007WA, SR821350216WA, SR821350218WA, SR821350217WA, SR821350215WA, SR821350213WA, SR821390094WA, SR821350116WA, SR821260013WA, SR821390092WA, SR821390090WA, SR822062014WA, SR822062013WA, SR822062009WA, SR822062012WA, SR822062008WA, SR822062001WA, SR822062007WA, SR822062003WA, SR821410050WA, SR821170026WA, SR821170024WA, SR821170027WA, SR821170022WA, SR821250037WA, SR821250028WA, SR821250030WA, SR821250031WA, SR821250035WA, SR821250038WA, SR821250029WA, SR821250033WA, SR821250034WA, SR821250036WA, SR821250032WA, SR821250039WA, SR821250040WA, SR821260041WA, SR821260071WA, SR821260077WA, SR821260040WA, SR821260070WA, SR821260072WA, SR821260073WA, SR821260074WA, SR821260075WA, SR821260076WA, SR821260028WA, SR821260038WA, SR821260039WA, SR821260029WA, SR821260037WA, SR821260031WA, SR821410083WA, SR821410080WA, SR821410078WA, SR821410075WA, SR821410073WA, SR821410082WA, SR821410079WA, SR821410077WA, SR821410081WA, SR821410070WA, SR821410076WA, SR821410074WA, SR821410072WA, SR821410049WA, SR821410053WA, SR821410055WA, SR821410057WA, SR821410062WA, SR821410052WA, SR821410056WA, SR821410058WA, SR821410061WA, SR821410066WA, SR821410054WA, SR821410059WA, SR821410060WA, SR821410065WA, SR821410069WA, SR821410064WA, SR821260062WA, SR821410011WA, SR821410013WA, SR821410012WA, SR821410014WA, SR821410015WA, SR821410016WA, SR821410010WA, SR821390103WA, SR821390101WA, SR821410117WA, SR821410116WA, SR821410115WA, SR821410114WA, SR821410113WA, SR821410109WA, SR821410112WA, SR821410111WA, SR821410108WA, SR821410110WA, SR821410092WA, SR821410107WA, SR821410106WA, SR821410105WA, SR821410097WA, SR821410104WA, SR821410103WA, SR821410102WA, SR821410094WA, SR821410099WA, SR821410096WA, SR821410098WA, SR821410095WA, SR821410091WA, SR821410093WA, SR821410090WA, SR821410043WA, SR821410089WA, SR821410088WA, SR821410087WA, SR821410085WA, SR821410084WA, SR821410041WA, SR821410063WA, SR821410051WA, SR821410048WA, SR821410046WA, SR821410045WA, SR821410047WA, SR821410044WA, SR821410042WA, SR821410040WA, SR821410039WA, SR821410034WA, SR821410031WA, SR821410007WA, SR821410006WA, SR821410038WA, SR821410037WA, SR821410035WA, SR821410036WA, SR821410032WA, SR821410030WA, SR821410033WA, SR821410029WA, SR821410028WA, SR821410008WA, SR821410027WA, SR821410026WA, SR821410009WA, SR821410003WA, SR821390130WA, SR821390140WA, SR821390138WA, SR821390131WA, SR821390132WA, SR821390129WA, SR821410004WA, SR821390133WA, SR821410005WA, SR821390136WA, SR821390116WA, SR821410002WA, SR821390128WA, SR821390137WA, SR821390135WA, SR821390134WA, SR821390139WA, SR821390127WA, SR821390126WA, SR821390125WA, SR821390108WA, SR821390124WA, SR821390113WA, SR821390121WA, SR821390118WA, SR821390107WA, SR821390109WA, SR821390111WA, SR821390112WA, SR821390117WA, SR821390110WA, SR821390122WA, SR821390120WA, SR821390119WA, SR821390123WA, SR821390115WA, SR821390114WA, SR821390104WA, SR821390105WA, SR821390102WA, SR821390106WA, SR821260055WA, SR821260054WA, SR821170031WA, SR821170032WA, SR822062002WA, SR821410118WA, SR821410100WA, SR821410101WA, SR821410119WA, SR821260053WA, SR821260048WA, SR821210016WA, SR821210018WA, SR821210014WA, SR821210020WA, SR821230027WA, SR821230062WA, SR821230061WA, SR821230042WA, SR821230041WA, SR821230039WA, SR821230036WA, SR821230035WA, SR821230055WA, SR821230053WA, SR821230054WA, SR821230016WA, SR821230018WA, SR821230022WA, SR821230024WA, SR821230065WA, SR821472050WA, SR821472049WA, SR821472052WA, SR821472053WA, SR821472054WA, SR821472055WA, SR821472056WA, SR821472057WA, SR821472058WA, SR821472059WA, SR821472060WA, SR821472061WA, SR821472042WA, SR821472043WA, SR821472044WA, SR821472045WA, SR821472046WA, SR821472047WA, SR821472048WA, SR821472051WA, SR822082030WA, SR822082035WA, SR822082031WA, SR822082029WA, SR822082033WA, SR822082038WA, SR822082032WA, SR822082037WA, SR822082034WA, SR822082036WA, SR821230050WA, SR821230051WA, SR821210013WA, SR821230034WA, SR821230043WA, SR821230031WA, SR821230032WA, SR821230047WA, SR821230014WA, SR821230021WA, SR821230025WA, SR821230060WA, SR821230059WA, SR821230058WA, SR821230052WA, SR821380084WA, SR821210011WA, SR821210015WA, SR821230001WA, SR821230003WA, SR821230004WA, SR821230005WA, SR821230006WA, SR821230007WA, SR821230008WA, SR821230009WA, SR821230012WA, SR821230066WA, SR821230067WA, SR821230068WA, SR821230069WA, SR821230070WA, SR821230071WA, SR821230072WA, SR821230073WA, SR821230074WA, SR821230075WA, SR821230076WA, SR821230077WA, SR821230078WA, SR821230079WA, SR821230080WA, SR821230081WA, SR821230082WA, SR821230083WA, SR821230084WA, SR821230085WA, SR821230086WA, SR821230002WA, SR821230064WA, SR821230048WA, SR821230046WA, SR821230026WA, SR821230028WA, SR821210019WA, SR821230019WA, SR821230029WA, SR821230049WA, SR821210017WA, SR821230040WA, SR821230038WA, SR821230037WA, SR821230017WA, SR821230013WA, SR821230015WA, SR821230020WA, SR821230023WA, SR821230030WA, SR821230063WA, SR821230056WA, SR821230057WA, SR821210012WA, SR821270043WA, SR821270046WA, SR821270047WA, SR821270045WA, SR821270044WA, SR821430033WA, SR822092010WA, SR822092009WA, SR821430031WA, SR822092008WA, SR821270048WA, SR821430032WA, SR821270081WA, SR821270082WA, SR821330039WA, SR821330040WA, SR821330041WA, SR821330042WA, SR821330043WA, SR821330044WA, SR821330045WA, SR821330046WA, SR821330047WA, SR821330048WA, SR821330049WA, SR821330050WA, SR821330051WA, SR821330052WA, SR821330053WA, SR821330054WA, SR821330055WA, SR821330056WA, SR821330057WA, SR821330058WA, SR821330059WA, SR821330060WA, SR821330061WA, SR821330062WA, SR821330063WA, SR821330064WA, SR821330065WA, SR821350001WA, SR821350002WA, SR821350003WA, SR821350004WA, SR821350005WA, SR821350006WA, SR821350007WA, SR821350008WA, SR821350009WA, SR821350010WA, SR821350011WA, SR821350012WA, SR821350013WA, SR821350014WA, SR821350015WA, SR821350016WA, SR821350017WA, SR821350018WA, SR821350019WA, SR821350020WA, SR821350021WA, SR821350022WA, SR821350023WA, SR821350024WA, SR821350025WA, SR821350026WA, SR821350027WA, SR821350028WA, SR821350029WA, SR821350030WA, SR821350031WA, SR821350032WA, SR821350033WA, SR821350034WA, SR821350035WA, SR821350036WA, SR821350037WA, SR821350038WA, SR821350039WA, SR821350040WA, SR821350041WA, SR821350126WA, SR821350127WA, SR821350128WA, SR821350129WA, SR821350130WA, SR821350131WA, SR821350132WA, SR821350133WA, SR821350134WA, SR821350135WA, SR821350136WA, SR821350137WA, SR821350138WA, SR821350139WA, SR821350140WA, SR821350141WA, SR821350145WA, SR821350142WA, SR821350143WA, SR821350144WA, SR821350146WA, SR821350147WA, SR821350148WA, SR821340018WA, SR821340015WA, SR821340016WA, SR821340017WA, SR821340019WA, SR821340020WA, SR821340021WA, SR821340022WA, SR821340023WA, SR821340024WA, SR821340025WA, SR821340026WA, SR821340027WA, SR821340028WA, SR821340029WA, SR821340110WA, SR821340111WA, SR821340112WA, SR821340113WA, SR821340114WA, SR821340115WA, SR821340116WA, SR821340117WA, SR821340118WA, SR821340119WA, SR821340120WA, SR821340121WA, SR821340122WA, SR821340123WA, SR821340124WA, SR821340125WA, SR821340094WA, SR821340095WA, SR821340096WA, SR821340097WA, SR821340098WA, SR821340099WA, SR821340100WA, SR821340101WA, SR821340102WA, SR821340103WA, SR821340104WA, SR821340105WA, SR821340106WA, SR821340107WA, SR821340108WA, SR821340109WA, SR821340078WA, SR821340079WA, SR821340080WA, SR821340081WA, SR821340082WA, SR821340083WA, SR821340084WA, SR821340085WA, SR821340086WA, SR821340087WA, SR821340088WA, SR821340089WA, SR821340093WA, SR821340090WA, SR821340091WA, SR821340092WA, SR821340062WA, SR821340063WA, SR821340064WA, SR821340065WA, SR821340066WA, SR821340067WA, SR821340068WA, SR821340069WA, SR821340070WA, SR821340071WA, SR821340072WA, SR821340073WA, SR821340074WA, SR821340075WA, SR821340076WA, SR821340077WA, SR821340046WA, SR821340047WA, SR821340048WA, SR821340049WA, SR821340050WA, SR821340051WA, SR821340052WA, SR821340053WA, SR821340054WA, SR821340055WA, SR821340056WA, SR821340057WA, SR821340058WA, SR821340059WA, SR821340060WA, SR821340061WA, SR821340030WA, SR821340031WA, SR821340032WA, SR821340033WA, SR821340034WA, SR821340035WA, SR821340036WA, SR821340037WA, SR821340038WA, SR821340039WA, SR821340040WA, SR821340041WA, SR821340042WA, SR821340043WA, SR821340044WA, SR821340045WA, SR821340001WA, SR821340002WA, SR821340003WA, SR821340004WA, SR821340005WA, SR821340006WA, SR821340007WA, SR821340008WA, SR821340009WA, SR821340010WA, SR821340011WA, SR821340012WA, SR821340013WA, SR821340014WA, SR821360313WA, SR821360314WA, SR821360315WA, SR821360316WA, SR821360317WA, SR821360318WA, SR821360319WA, SR821360320WA, SR821360324WA, SR821360325WA, SR821360326WA, SR821360327WA, SR821360328WA, SR821360329WA, SR821360330WA, SR821360331WA, SR821360332WA, SR821360333WA, SR821360334WA, SR821360335WA, SR821360293WA, SR821360294WA, SR821360295WA, SR821360296WA, SR821360297WA, SR821360298WA, SR821360299WA, SR821360300WA, SR821360301WA, SR821360302WA, SR821360303WA, SR821360304WA, SR821360305WA, SR821360306WA, SR821360307WA, SR821360308WA, SR821360309WA, SR821360310WA, SR821360311WA, SR821360312WA, SR821350273WA, SR821350274WA, SR821360275WA, SR821360276WA, SR821360277WA, SR821360278WA, SR821360279WA, SR821360280WA, SR821360281WA, SR821360282WA, SR821360283WA, SR821360284WA, SR821360285WA, SR821360286WA, SR821360287WA, SR821360288WA, SR821360289WA, SR821360290WA, SR821360291WA, SR821360292WA, SR821350253WA, SR821350254WA, SR821350255WA, SR821350256WA, SR821350257WA, SR821350258WA, SR821350259WA, SR821350260WA, SR821350261WA, SR821350262WA, SR821350263WA, SR821350264WA, SR821350265WA, SR821350266WA, SR821350267WA, SR821350268WA, SR821350269WA, SR821350270WA, SR821350271WA, SR821350272WA, SR821350233WA, SR821350234WA, SR821350235WA, SR821350236WA, SR821350237WA, SR821350238WA, SR821350239WA, SR821350240WA, SR821350241WA, SR821350242WA, SR821350243WA, SR821350244WA, SR821350245WA, SR821350246WA, SR821350247WA, SR821350248WA, SR821350249WA, SR821350250WA, SR821350251WA, SR821350252WA, SR821350223WA, SR821350224WA, SR821350225WA, SR821350226WA, SR821350227WA, SR821350228WA, SR821350229WA, SR821350230WA, SR821350231WA, SR821350232WA, SR821360051WA, SR821360052WA, SR821360053WA, SR821360054WA, SR821360055WA, SR821360056WA, SR821360057WA, SR821360058WA, SR821360059WA, SR821360060WA, SR821360061WA, SR821360062WA, SR821360063WA, SR821360064WA, SR821360065WA, SR821360066WA, SR821360067WA, SR821360068WA, SR821360069WA, SR821360070WA, SR821360031WA, SR821360032WA, SR821360033WA, SR821360034WA, SR821360035WA, SR821360036WA, SR821360037WA, SR821360038WA, SR821360039WA, SR821360040WA, SR821360041WA, SR821360042WA, SR821360043WA, SR821360044WA, SR821360045WA, SR821360046WA, SR821360047WA, SR821360048WA, SR821360049WA, SR821360050WA, SR821360021WA, SR821360022WA, SR821360023WA, SR821360024WA, SR821360025WA, SR821360026WA, SR821360027WA, SR821360028WA, SR821360029WA, SR821360030WA, SR821350221WA, SR821350222WA, SR821360001WA, SR821360002WA, SR821360003WA, SR821360004WA, SR821360005WA, SR821360006WA, SR821360007WA, SR821360008WA, SR821360009WA, SR821360010WA, SR821360011WA, SR821360012WA, SR821360013WA, SR821360014WA, SR821360015WA, SR821360016WA, SR821360017WA, SR821360018WA, SR821360019WA, SR821360020WA, SR821350046WA, SR821350043WA, SR821350044WA, SR821350045WA, SR821350047WA, SR821350048WA, SR821350049WA, SR821350050WA, SR821350051WA, SR821350052WA, SR821350053WA, SR821350054WA, SR821350055WA, SR821350056WA, SR821350057WA, SR821350058WA, SR821350059WA, SR821350060WA, SR821350061WA, SR821350062WA, SR821350063WA, SR821350064WA, SR821350065WA, SR821350066WA, SR821350067WA, SR821350068WA, SR821350069WA, SR821350070WA, SR821350071WA, SR821350072WA, SR821350073WA, SR821350074WA, SR821350075WA, SR821350076WA, SR821350077WA, SR821350078WA, SR821350079WA, SR821350083WA, SR821350080WA, SR821350081WA, SR821350082WA, SR821350084WA, SR821350085WA, SR821350086WA, SR821350087WA, SR821350088WA, SR821350089WA, SR821350090WA, SR821350091WA, SR821350092WA, SR821240016WA, SR822192020WA, SR822192019WA, SR822352016WA, SR822352017WA, SR821240007WA, SR821240008WA, SR821240006WA, SR821240005WA, SR821240010WA, SR821240002WA, SR821240004WA, SR821240012WA, SR821240011WA, SR821240015WA, SR821240013WA, SR821240014WA, SR821240009WA, SR821240003WA, SR821410136WA, SR821410134WA, SR821410138WA, SR821410135WA, SR821410137WA, SR821472093WA, SR821472094WA, SR821472097WA, SR821472096WA, SR821472095WA, SR821420029WA, SR822082008WA, SR821410131WA, SR821410130WA; Model Number 6160000-005-01034529, Serial Numbers: SR822300011SA; Model Number 6160000-005-01034935, Serial Numbers: SR822372081WA, SR822372082WA, SR822372083WA; Model Number 6160000-005-01037462, Serial Numbers: SR822242066WA, SR822242067WA; Model Number 6160000-005-01040230, Serial Numbers: SR822352023WA, SR822352024WA; Model Number 6160000-005-01040493, Serial Numbers: SR822352003WA; Model Number 6160000-005-01040973, Serial Numbers: SR822372001WA, SR822372002WA, SR822372003WA, SR822372004WA, SR822372005WA, SR822372006WA, SR822372007WA, SR822372008WA; Model Number 6160000-005-01041891, Serial Numbers: SR822352025WA; Model Number 6160000-005-01044070, Serial Numbers: SR822372024WA, SR822372025WA, SR822372026WA, SR822372027WA, SR822372028WA, SR822372029WA, SR822372030WA, SR822372031WA, SR822372032WA, SR822372033WA, SR822372034WA, SR822372035WA; Model Number 6160000-005-01045083, Serial Numbers: SR822370031SA, SR822370028SA, SR822370029SA, SR822370030SA, SR822370032SA, SR822370033SA, SR822370034SA, SR822370035SA, SR822370036SA, SR822370037SA, SR822370038SA, SR822370039SA, SR822370040SA, SR822370041SA, SR822370042SA, SR822370043SA, SR822370044SA, SR822380001SA, SR822380005SA, SR822380002SA, SR822380003SA, SR822380004SA, SR822380006SA, SR822380007SA, SR822380008SA, SR822380009SA, SR822380010SA, SR822380011SA, SR822380012SA, SR822380013SA; Model Number 6160000-005-01047682, Serial Numbers: SR822352026WA; Model Number 6160000-005-01055187, Serial Numbers: SR822362001WA; Model Number 6160000-005-01055663, Serial Numbers: SR822342120WA, SR822342121WA, SR822342122WA, SR822342123WA, SR822342124WA; Model Number 6160000-005-01058503, Serial Numbers: SR822362023WA; Model Number 6160000-005-01059067, Serial Numbers: SR822322002WA, SR822322003WA; Model Number 6160000-005-01060073, Serial Numbers: SR822372009WA; Model Number 6160000-005-01065235, Serial Numbers: SR822322009WA; Model Number 6160000-005-01068737, Serial Numbers: SR822362044WA, SR822362045WA, SR822362046WA; Model Number 6160000-005-01070459, Serial Numbers: SR822342033WA, SR822342034WA, SR822342035WA, SR822342036WA, SR822342037WA, SR822342038WA, SR822342039WA, SR822342040WA, SR822342041WA, SR822342042WA, SR822342043WA, SR822342044WA, SR822342045WA, SR822342046WA, SR822342047WA, SR822342048WA, SR822342049WA, SR822342050WA, SR822342051WA, SR822342052WA, SR822342053WA, SR822342054WA, SR822342055WA, SR822342056WA, SR822342057WA, SR822342058WA, SR822342059WA, SR822342060WA, SR822342061WA, SR822342062WA, SR822342063WA; Model Number 6160000-005-01073653, Serial Numbers: SR822342210WA; Model Number 6160000-005-01075212, Serial Numbers: SR822372020WA, SR822372017WA, SR822372018WA, SR822372019WA, SR822372021WA; Model Number 6160000-005-100174, Serial Numbers: SR822202005WA, SR822202006WA, SR822202007WA, SR822202008WA, SR822202009WA, SR822202010WA, SR822202011WA, SR822192029WA, SR822192023WA, SR822192024WA, SR822192072WA, SR822192073WA, SR822202017WA, SR822192025WA, SR822192026WA, SR822192027WA, SR822192028WA, SR822192030WA, SR822192031WA, SR822192032WA, SR822192033WA, SR822192068WA, SR822192034WA, SR822192035WA, SR822192067WA, SR822192069WA, SR822192070WA, SR822192071WA, SR822192077WA, SR822192074WA, SR822192075WA, SR822192076WA, SR822192078WA, SR822192079WA, SR822192080WA, SR822192081WA, SR822192082WA, SR822202002WA, SR822192083WA, SR822192084WA, SR822202001WA, SR822202003WA, SR822202004WA, SR822202012WA, SR822202013WA, SR822202014WA, SR822202015WA, SR822202016WA; Model Number 6160000-005-100380, Serial Numbers: SR822342065WA, SR822342066WA, SR822342067WA, SR822342068WA, SR822342069WA, SR822342070WA, SR822342071WA, SR822342072WA, SR822342073WA, SR822342074WA, SR822342075WA, SR822342076WA; Model Number 6160000-005-101193, Serial Numbers: SR822342125WA; Model Number 6160000-005-101349, Serial Numbers: SR822342126WA, SR822342127WA, SR822342128WA, SR822342129WA, SR822342130WA, SR822342131WA, SR822342132WA, SR822342133WA, SR822342134WA, SR822342135WA, SR822342167WA, SR822342168WA, SR822342169WA, SR822342170WA, SR822342171WA, SR822342172WA, SR822342173WA, SR822342174WA, SR822342175WA, SR822342176WA, SR822342177WA, SR822342178WA; Model Number 6160000-005-101360, Serial Numbers: SR822352029WA, SR822352030WA, SR822352031WA, SR822352032WA, SR822352033WA, SR822352034WA, SR822362035WA, SR822362036WA, SR822362037WA; Model Number 6160000-005-101423, Serial Numbers: SR822342118WA; Model Number 6160000-005-101493, Serial Numbers: SR822202039WA, SR822202040WA, SR822202041WA, SR822202042WA, SR822202043WA, SR822202044WA, SR822202045WA; Model Number 6160000-005-101526, Serial Numbers: SR822342151WA; Model Number 6160000-005-101762, Serial Numbers: SR822261001PA, SR822261002PA, SR822261007PA, SR822261012PA, SR822261006PA, SR822271002PA, SR822281005PA, SR822271004PA, SR822281002PA, SR822281001PA, SR822281010PA, SR822271006PA, SR822261003PA, SR822261004PA, SR822281003PA, SR822261011PA, SR822271005PA, SR822271001PA, SR822261005PA, SR822261008PA, SR822261010PA; Model Number 6160000-005-101927, Serial Numbers: SR822342179WA, SR822342180WA, SR822342181WA, SR822342182WA, SR822342183WA, SR822342184WA, SR822342185WA; Model Number 6160000-005-102184, Serial Numbers: SR822342213WA, SR822342214WA; Model Number 6160000-005-704368, Serial Numbers: SR820510003WA, SR820510005WA, SR820510006WA; Model Number 6160000-005-704596, Serial Numbers: SR820510004WA; Model Number 6160000-005-704823, Serial Numbers: SR820510001WA; Model Number 6160000-005-708150, Serial Numbers: SR821040020WA, SR821040021WA, SR820470006WA, SR821010002WA, SR821010001WA, SR821040023WA, SR821040019WA, SR821040022WA, SR821030008WA, SR821040018WA, SR820470001WA, SR820470009WA, SR821040027WA, SR821040024WA, SR821040025WA, SR821040026WA, SR821040028WA, SR821040032WA, SR821040029WA, SR821040030WA, SR821040031WA, SR821040033WA, SR821040034WA, SR821040035WA, SR821040036WA, SR821040037WA; Model Number 6160000-005-711765, Serial Numbers: SR820510021WA, SR820510022WA, SR820510017WA, SR820510018WA, SR820510019WA, SR820510020WA; Model Number 6160000-005-721726, Serial Numbers: SR820490004WA, SR820490001WA, SR820490002WA, SR820490003WA, SR820490005WA; Model Number 6160000-005-722131, Serial Numbers: SR820510007WA; Model Number 6160000-005-722132, Serial Numbers: SR820510008WA, SR820510009WA, SR820510010WA, SR820510011WA, SR820510012WA, SR820510013WA, SR820510014WA, SR820510015WA, SR820510016WA; Model Number 6160000-005-723474, Serial Numbers: SR821060014WA, SR821060015WA, SR821060016WA, SR821060017WA, SR821060018WA, SR821060019WA; Model Number 6160000-005-723475, Serial Numbers: SR821060020WA, SR821060021WA, SR821060022WA, SR821060023WA, SR821060024WA, SR821060025WA, SR821080008WA, SR821080009WA, SR821080010WA, SR821080011WA, SR821080012WA, SR821080013WA, SR821080014WA, SR821080015WA, SR821080016WA, SR821080017WA; Model Number 6160000-005-725518, Serial Numbers: SR820510023WA; Model Number 6160000-005-725519, Serial Numbers: SR820510024WA, SR821110003WA, SR821110004WA, SR821110005WA; Model Number 6160000-005-726236, Serial Numbers: SR820510025WA, SR820510026WA, SR820510027WA; Model Number 6160000-005-726238, Serial Numbers: SR820510028WA; Model Number 6160000-005-727965, Serial Numbers: SR821050039WA, SR821050040WA, SR821050041WA; Model Number 6160000-005-729094, Serial Numbers: SR821040005WA; Model Number 6160000-005-742229, Serial Numbers: SR821040016WA, SR821040017WA; Model Number 6160000-005-749235, Serial Numbers: SR821040059WA, SR821040060WA; Model Number 6160000-005-749421, Serial Numbers: SR821030001WA, SR821030002WA, SR821030003WA, SR821030009WA, SR821030010WA, SR821030011WA, SR821030012WA, SR821030013WA, SR821030014WA, SR821030015WA, SR821030016WA, SR821030017WA, SR821030018WA, SR821030019WA, SR821030020WA, SR821030021WA, SR821030022WA, SR821030023WA, SR821030024WA, SR821030025WA, SR821030026WA, SR821030027WA, SR821030028WA, SR821030029WA, SR821030030WA, SR821030031WA, SR821030032WA, SR821030033WA, SR821030034WA, SR821030035WA, SR821030036WA, SR821030037WA, SR821030038WA, SR821030039WA, SR821030040WA, SR821030041WA, SR821030042WA, SR821030043WA, SR821030044WA, SR821030045WA, SR821030046WA, SR821030047WA, SR821030048WA, SR821030049WA, SR821030050WA, SR821030051WA, SR821030052WA, SR821030053WA, SR821030054WA, SR821030055WA; Model Number 6160000-005-749817, Serial Numbers: SR821040008WA, SR821040009WA, SR821040010WA, SR821040011WA, SR821040012WA, SR821040013WA, SR821040014WA, SR821040015WA; Model Number 6160000-005-750434, Serial Numbers: SR821040003WA; Model Number 6160000-005-751082, Serial Numbers: SR821030056WA; Model Number 6160000-005-753162, Serial Numbers: SR821050002WA, SR821050004WA, SR821050005WA, SR821050006WA, SR821050007WA, SR821050008WA, SR821050010WA, SR821050011WA, SR821050012WA, SR821050013WA, SR821050014WA, SR821050015WA, SR821050016WA, SR821050017WA, SR821050018WA, SR821050019WA, SR821050020WA, SR821050021WA, SR821050022WA, SR821050023WA, SR821050024WA, SR821050025WA, SR821050027WA, SR821050028WA, SR821050029WA, SR821050031WA, SR821050032WA, SR821050033WA, SR821050035WA, SR821050036WA, SR821050026WA, SR821050030WA, SR821050003WA, SR821050009WA; Model Number 6160000-005-754533, Serial Numbers: SR821050001WA; Model Number 6160000-005-754961, Serial Numbers: SR821060005WA, SR821060006WA, SR821060007WA, SR821060008WA, SR821060009WA, SR821060010WA, SR821060011WA, SR821060012WA, SR821060013WA; Model Number 6160000-005-754963, Serial Numbers: SR821060002WA, SR821060003WA, SR821060004WA; Model Number 6160000-005-755219, Serial Numbers: SR821080006WA, SR821080007WA; Model Number 6160000-005-755228, Serial Numbers: SR821050038WA; Model Number 6160000-005-757518, Serial Numbers: SR821050037WA; Model Number 6160000-005-761729, Serial Numbers: SR821060001WA, Model Number 6160000-005-762207, Serial Numbers: SR821050045WA; Model Number 6160000-005-765421, Serial Numbers: SR821100002WA; Model Number 6160000-005-766229, Serial Numbers: SR821080005WA, SR821080004WA; Model Number 6160000-005-766230, Serial Numbers: SR821080002WA, SR821080003WA; Model Number 6160000-005-771641, Serial Numbers: SR821080018WA; Model Number 6160000-005-771661, Serial Numbers: SR821160001WA; Model Number 6160000-005-778744, Serial Numbers: SR821100001WA; Model Number 6160000-005-790603, Serial Numbers: SR821130002WA, SR821130003WA, SR821130004WA, SR821160004WA, SR821160006WA, SR821160003WA, SR821160005WA, SR821130005WA, SR821130006WA, SR821160002WA,; Model Number 6160000-005-790655, Serial Numbers: SR821130007WA, SR821130008WA, SR821130009WA, SR821130010WA, SR821130011WA; Model Number 6160000-005-790747, Serial Numbers: SR821150011WA, SR821310053WA, SR822352005WA, SR821150012WA, SR821220020WA, SR821220025WA, SR821220026WA, SR821220017WA, SR821220018WA, SR821220019WA, SR821220021WA, SR821220027WA, SR821220022WA, SR821220023WA, SR821220024WA, SR821310055WA, SR821310056WA, SR821310057WA, SR821310058WA, SR822152009WA, SR822152007WA, SR822152008WA, SR821150006WA, SR821310052WA, SR821160013WA, SR821310050WA, SR821310049WA, SR822352006WA, SR821180040WA, SR821310054WA, SR821320044WA, SR821390100WA, SR821390099WA, SR822342002WA; Model Number 6160000-005-790909, Serial Numbers: SR821130001WA; Model Number 6160000-005-790959, Serial Numbers: SR821140004WA, SR821140001WA, SR821140002WA, SR821140003WA, SR821140008WA, SR821140005WA, SR821140006WA, SR821140007WA, SR821140009WA; Model Number 6160000-005-794329, Serial Numbers: SR821452071WA, SR821452072WA, SR821452073WA, SR821452075WA, SR821452076WA, SR821452077WA, SR821452080WA, SR821452067WA, SR821452068WA, SR821452069WA, SR821230011WA, SR821250014WA, SR821250011WA, SR821250012WA, SR821250013WA, SR821250015WA, SR821250016WA, SR821250017WA, SR821250018WA, SR821250019WA, SR821250020WA, SR821380010WA, SR821452074WA, SR821452078WA, SR821452079WA, SR821452070WA, SR821492029WA, SR821492030WA, SR822032010WA, SR822112027WA, SR822112024WA, SR822112025WA, SR822112026WA, SR822112028WA, SR822082058WA, SR822082039WA, SR822082046WA, SR822222043WA, SR822222042WA, SR821492031WA, SR821360323WA, SR821360322WA, SR821380009WA, SR821380012WA, SR821380011WA, SR821512012WA, SR822062033WA, SR822082048WA, SR822082043WA, SR822082044WA, SR822082047WA, SR822082051WA, SR822082053WA, SR822222037WA, SR822222034WA, SR822222035WA, SR822222036WA, SR822222038WA, SR822222039WA, SR822222041WA, SR822222040WA, SR822372040WA, SR822372041WA, SR822372042WA, SR822372043WA, SR821330068WA, SR821330066WA, SR821330067WA, SR822062020WA, SR822062019WA, SR822082050WA, SR822082049WA, SR822082040WA, SR822122008WA, SR822122005WA, SR822122006WA, SR822122007WA, SR822122009WA, SR822122010WA, SR822122011WA, SR822122012WA, SR822122013WA, SR822122014WA, SR822212006WA, SR822212004WA, SR822212005WA, SR822222033WA, SR822222078WA, SR822222076WA, SR822222077WA, SR822222079WA, SR822232042WA, SR822232040WA, SR822232041WA, SR822212007WA, SR822192018WA, SR822192015WA, SR822192016WA, SR822192017WA, SR821240019WA, SR821240018WA, SR821410129WA, SR822352251WA, SR821370004WA, SR821370002WA, SR821370001WA, SR821370003WA, SR821462092WA, SR821462089WA, SR821462090WA, SR821462091WA, SR822032017WA, SR822032014WA, SR822032015WA, SR822032016WA, SR822032019WA, SR822032018WA, SR822082056WA, SR822082054WA, SR822082055WA, SR822192008WA, SR822192005WA, SR822192006WA, SR822192007WA, SR822192004WA, SR822192003WA, SR822192009WA, SR822192013WA, SR822192010WA, SR822192011WA, SR822202023WA, SR822202022WA, SR822202021WA, SR822202019WA, SR822202020WA, SR822232036WA, SR822232035WA, SR822232039WA, SR822232037WA, SR822232038WA, SR822202018WA, SR822222051WA, SR822222048WA, SR822222049WA, SR822222050WA, SR822222047WA, SR822222044WA, SR822222045WA, SR822222046WA, SR822222053WA, SR822222052WA, SR822342001WA, SR822342003WA, SR822372067WA, SR822382009WA, SR822382007WA, SR822382008WA, SR822382005WA, SR822382004WA, SR822392013WA, SR822192012WA, SR822122004WA, SR822122001WA, SR822122002WA, SR822122003WA, SR822062022WA, SR822062021WA, SR822062023WA, SR822062024WA, SR822062025WA, SR822062026WA, SR822062027WA, SR822062028WA, SR822062029WA, SR822062030WA, SR822062031WA, SR822062032WA, SR822062034WA, SR822072001WA, SR822072002WA, SR822202036WA, SR822202024WA, SR822202025WA, SR822202026WA, SR822202027WA, SR822202028WA, SR822202029WA, SR822202030WA, SR822202031WA, SR822202032WA, SR822202033WA, SR822202034WA, SR822202038WA, SR822202035WA, SR822202037WA, SR822252001WA, SR821240023WA, SR822082052WA, SR822372010WA, SR822362004WA, SR822362002WA, SR822362003WA, SR822392012WA, SR822392011WA, SR821472024WA, SR822122023WA, SR822122021WA, SR822122022WA, SR822212015WA, SR822212010WA, SR822272001WA, SR822382006WA, SR822212014WA, SR822212013WA, SR822212008WA, SR822212009WA, SR822212011WA, SR822212012WA, SR822012001WA, SR822122018WA, SR822122015WA, SR822122016WA, SR822122017WA, SR822122019WA, SR822122020WA, SR822132004WA, SR822132001WA, SR822132002WA, SR822132003WA, SR822132005WA, SR822132006WA, SR822132007WA, SR822132008WA, SR822132009WA, SR822132010WA, SR822232048WA, SR821380007WA, SR822222074WA, SR822222071WA, SR822222072WA, SR822222073WA, SR822222075WA, SR822232049WA, SR822232033WA, SR822232032WA, SR822082057WA, SR821512036WA, SR821512034WA, SR821512035WA, SR821482001WA, SR822112023WA, SR822112022WA, SR822372076WA, SR822372075WA, SR822392015WA, SR822392014WA, SR821462088WA, SR821462086WA, SR821462087WA, SR822382087WA, SR822382084WA, SR822382085WA, SR822382086WA, SR822382088WA, SR822382089WA, SR821512009WA, SR821512006WA, SR821512007WA, SR821512008WA, SR821512010WA, SR821512011WA, SR821502034WA, SR821240017WA, SR821250008WA, SR822372071WA, SR822372068WA, SR822372069WA, SR822372070WA, SR822372072WA, SR822372023WA, SR822372022WA, SR822192058WA, SR822192055WA, SR822192056WA, SR822192057WA, SR822192059WA, SR822192060WA, SR822192061WA, SR822192062WA, SR822192063WA, SR822192064WA, SR822192065WA, SR822192066WA, SR822192050WA, SR822192047WA, SR822192048WA, SR822192049WA, SR822192051WA, SR822192052WA, SR822192053WA, SR822192054WA, SR821320012WA, SR821330003WA, SR821330001WA, SR821330002WA, SR821430046WA, SR821472009WA, SR821482067WA, SR821482065WA, SR821482066WA, SR821492028WA, SR821492026WA, SR821492027WA, SR821512023WA, SR821512018WA, SR821512019WA, SR821512020WA, SR821512021WA, SR821512022WA, SR821512024WA, SR821512025WA, SR821512026WA, SR821512027WA, SR821512028WA, SR821512029WA, SR821512030WA, SR821512031WA, SR821512032WA, SR821512033WA, SR821512040WA, SR821512037WA, SR821512038WA, SR821512039WA, SR821512041WA, SR821512042WA, SR821512043WA, SR821512046WA, SR821512044WA, SR821512045WA, SR822012008WA, SR822012005WA, SR822012006WA, SR822012007WA, SR822012009WA, SR822012010WA, SR822012011WA, SR822012012WA, SR822012013WA, SR822012014WA, SR822012015WA, SR822012004WA, SR822012002WA, SR822012003WA, SR822222020WA, SR822222017WA, SR822222018WA, SR822222019WA, SR822222021WA, SR822222022WA, SR822222023WA, SR822222024WA, SR822222025WA, SR822222026WA, SR822222027WA, SR822222028WA, SR822222029WA, SR822222030WA, SR822222031WA, SR822222032WA, SR822222004WA, SR822222001WA, SR822222002WA, SR822222003WA, SR822222005WA, SR822222006WA, SR822222007WA, SR822222008WA, SR822222009WA, SR822222013WA, SR822222010WA, SR822222011WA, SR822222012WA, SR822222014WA, SR822222015WA, SR822222016WA, SR822232034WA, SR822252003WA, SR822252002WA, SR822372047WA, SR822372044WA, SR822372045WA, SR822372046WA, SR822372078WA, SR822372077WA, SR822232031WA, SR822242001WA, SR822372048WA, SR821320043WA, SR821512005WA, SR822082061WA, SR822082059WA, SR822082060WA, SR822232053WA, SR822232050WA, SR822232051WA, SR822232052WA, SR822232054WA, SR822232055WA, SR822232056WA, SR822232057WA, SR822232058WA, SR822232059WA, SR822232060WA, SR822232061WA, SR822232062WA, SR821270053WA, SR821270052WA, SR822362050WA, SR822362047WA, SR822362048WA, SR822362049WA, SR822362051WA, SR821250010WA, SR821250009WA, SR821430015WA, SR821430014WA, SR82208
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0733-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026