Z-0732-2023 Class II Ongoing

Recalled by GE Medical Systems, LLC — Waukesha, WI

FDA device recall Z-0732-2023 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: 5962.

Recall Details

Product Type
Devices
Report Date
Dec 28, 2022
Initiation Date
Nov 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5962

Product Description

B125M Patient Monitor, REF 6160000-004-XXXXXX

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 00840682146715: Model Number 6160000-004, Serial Numbers: SR722210034SA, SR722210037SA, SR722210030SA, SR722210040SA, SR722210042SA, SR722210039SA, SR722210041SA, SR722220001SA, SR722210029SA, SR722220004SA, SR722220005SA, SR722210031SA, SR722210032SA, SR722220002SA, SR722210035SA, SR722210038SA, SR722210033SA, SR722210028SA, SR722220003SA, SR722210036SA, SR722180001SA, SR722090020WA, SR722090001WA, SR722090013WA, SR722090010WA, SR722090019WA, SR722090024WA, SR722090006WA, SR722090018WA, SR722090025WA, SR722090012WA, SR722090022WA, SR722090021WA, SR722090008WA, SR722090015WA, SR722090009WA, SR722090011WA, SR722090005WA, SR722090004WA, SR722090023WA, SR722090017WA, SR722090002WA, SR722090016WA, SR722090014WA, SR722090007WA, SR722090003WA, SR722340009SA, SR722260035SA, SR722260034SA, SR722260040SA, SR722260029SA, SR722260038SA, SR722260041SA, SR722260032SA, SR722260042SA, SR722260037SA, SR722260026SA, SR722260025SA, SR722260028SA, SR722260024SA, SR722260030SA, SR722260031SA, SR722260033SA, SR722260039SA, SR722260036SA, SR722260027SA, SR722340010SA, SR722340016SA, SR722340011SA, SR722340013SA, SR722340157SA, SR722340012SA, SR722340017SA, SR722210023SA, SR722210010SA, SR722210011SA, SR722210025SA, SR722210019SA, SR722210012SA, SR722210008SA, SR722210013SA, SR722210018SA, SR722210021SA, SR722210014SA, SR722210016SA, SR722210024SA, SR722210026SA, SR722210017SA, SR722210015SA, SR722210009SA, SR722210020SA, SR722210022SA, SR722210007SA, SR722210027SA, SR722300002SA, SR722330067SA, SR722330068SA, SR722330070SA, SR722330071SA, SR722330066SA, SR722330069SA, SR722170006SA, SR722170004SA, SR722170005SA, SR722170003SA, SR722170007SA, SR722170001SA, SR722170002SA; Model Number 6160000-004-01033170, Serial Numbers: SR722350377WA, SR722350378WA; Model Number 6160000-004-01034790, Serial Numbers: SR722370131WA, SR722370128WA, SR722370129WA, SR722370130WA, SR722370132WA, SR722370133WA, SR722370134WA, SR722370135WA, SR722370136WA, SR722370137WA, SR722370138WA, SR722370139WA, SR722370140WA, SR722370141WA, SR722370127WA, SR722370125WA, SR722370126WA; Model Number 6160000-004-01036427, Serial Numbers: SR722220018WA, SR722220016WA, SR722220017WA; Model Number 6160000-004-01036518, Serial Numbers: SR722330072SA; Model Number 6160000-004-01036836, Serial Numbers: SR722320011WA, SR722320008WA, SR722320009WA, SR722320010WA, SR722320012WA, SR722320013WA; Model Number 6160000-004-01040730, Serial Numbers: SR722350150WA, SR722350148WA, SR722350149WA; Model Number 6160000-004-01040802, Serial Numbers: SR722370342WA, SR722370341WA, SR722370343WA, SR722370344WA, SR722370345WA, SR722370346WA, SR722370347WA, SR722370348WA; Model Number 6160000-004-01051951, Serial Numbers: SR722360282WA, SR722360279WA, SR722360280WA, SR722360281WA, SR722360283WA, SR722360284WA, SR722360285WA; Model Number 6160000-004-01054042, Serial Numbers: SR722350045WA, SR722350042WA, SR722350043WA, SR722350044WA, SR722350046WA, SR722350047WA, SR722350048WA, SR722350049WA, SR722350050WA, SR722350051WA; Model Number 6160000-004-01054990, Serial Numbers: SR722380219SA, SR722380216SA, SR722380217SA, SR722380218SA, SR722380220SA, SR722380221SA, SR722380222SA, SR722380223SA, SR722380224SA, SR722380225SA, SR722380226SA, SR722380227SA, SR722380228SA, SR722380229SA, SR722380230SA; Model Number 6160000-004-01055026, Serial Numbers: SR722320053WA, SR722320052WA; Model Number 6160000-004-01055524, Serial Numbers: SR722320042WA; Model Number 6160000-004-01058339, Serial Numbers: SR722320043WA; Model Number 6160000-004-01059539, Serial Numbers: SR722360176WA; Model Number 6160000-004-01064964, Serial Numbers: SR722320054WA; Model Number 6160000-004-01069980, Serial Numbers: SR722330001SA; SR722330002SA, SR722320108SA, SR722320041SA, SR722320106SA, SR722320107SA, SR722320109SA, SR722330003SA; Model Number 6160000-004-01073870, Serial Numbers: SR722360043SA; Model Number 6160000-004-01074082, Serial Numbers: SR722360302SA, SR722360291SA, SR722360300SA, SR722360301SA, SR722360304SA, SR722360305SA, SR722360306SA, SR722360307SA, SR722360308SA, SR722360309SA, SR722360310SA, SR722370012SA, SR722370014SA, SR722370015SA, SR722370019SA, SR722370016SA, SR722370017SA, SR722370018SA, SR722370020SA, SR722370021SA, SR722370058SA, SR722370022SA, SR722370024SA, SR722370025SA, SR722370026SA, SR722370041SA, SR722370045SA, SR722370056SA, SR722370060SA, SR722370063SA, SR722370064SA, SR722370065SA, SR722370066SA, SR722370067SA, SR722370068SA, SR722370069SA, SR722370075SA, SR722370070SA, SR722370071SA, SR722370074SA, SR722370076SA, SR722370077SA, SR722370078SA, SR722370079SA, SR722370080SA, SR722370081SA, SR722370082SA, SR722370083SA, SR722370084SA, SR722370085SA, SR722370091SA, SR722370095SA, SR722370092SA, SR722370093SA, SR722370094SA, SR722370096SA, SR722370097SA, SR722370098SA, SR722370099SA, SR722370100SA; Model Number 6160000-004-01074097, Serial Numbers: SR722360045SA, SR722360044SA; Model Number 6160000-004-01074597, Serial Numbers: SR722320110SA, SR722320020SA, SR722320017SA, SR722320018SA, SR722320019SA, SR722320021SA, SR722320022SA, SR722320023SA, SR722320024SA, SR722320025SA, SR722320026SA, SR722320027SA, SR722320028SA, SR722320029SA, SR722320030SA, SR722320016SA, SR722320015SA; Model Number 6160000-004-01075297, Serial Numbers: SR722330043SA; Model Number 6160000-004-01075302, Serial Numbers: SR722320014SA, SR722320012SA, SR722320013SA; Model Number 6160000-004-01075671, Serial Numbers: SR722340004SA, SR722330097SA, SR722330098SA, SR722340003SA, SR722340005SA, SR722340006SA, SR722340007SA, SR722340008SA, SR722360036SA, SR722360031SA, SR722360032SA, SR722360033SA, SR722360034SA, SR722360035SA, SR722360037SA, SR722360038SA, SR722360039SA, SR722330023SA, SR722330020SA, SR722330021SA, SR722330022SA, SR722330024SA, SR722330025SA, SR722330026SA, SR722330027SA, SR722330028SA, SR722330029SA; Model Number 6160000-004-01075962, Serial Numbers: SR722320112SA, SR722320111SA; Model Number 6160000-004-01076630, Serial Numbers: SR722330036SA, SR722330042SA, SR722330030SA, SR722330031SA, SR722330032SA, SR722330033SA, SR722330034SA, SR722330035SA, SR722330037SA, SR722330038SA, SR722330039SA, SR722330040SA, SR722330041SA, SR722380196SA, SR722380106SA, SR722380107SA, SR722380195SA, SR722380197SA, SR722380198SA, SR722380199SA, SR722360161SA, SR722360158SA, SR722360159SA, SR722360160SA, SR722360295SA, SR722360297SA, SR722360299SA, SR722360294SA, SR722360165SA, SR722360162SA, SR722360163SA, SR722360164SA, SR722360166SA, SR722360167SA; Model Number 6160000-004-01080487, Serial Numbers: SR722340021SA, SR722340018SA, SR722340019SA, SR722340020SA, SR722340022SA, SR722340023SA, SR722340024SA, SR722340025SA, SR722340026SA, SR722340027SA, SR722340028SA, SR722340029SA, SR722340030SA, SR722340031SA, SR722380204SA, SR722380201SA, SR722380202SA, SR722380203SA, SR722380205SA, SR722380206SA, SR722380210SA, SR722380207SA, SR722380208SA, SR722380209SA, SR722380211SA, SR722380212SA, SR722380213SA, SR722380214SA, SR722380215SA; Model Number 6160000-004-01081047, Serial Numbers: SR722360042SA, SR722360040SA, SR722360041SA; Model Number 6160000-004-01081735, Serial Numbers: SR722360226SA, SR722360223SA, SR722360224SA, SR722360225SA, SR722360227SA, SR722360228SA, SR722360229SA, SR722360230SA, SR722360231SA, SR722360232SA, SR722360233SA, SR722360234SA, SR722360235SA, SR722360236SA, SR722360237SA, SR722360238SA, SR722360239SA, SR722360240SA, SR722360241SA; Model Number 6160000-004-01083940, Serial Numbers: SR722350013SA, SR722350010SA, SR722350011SA, SR722350012SA; Model Number 6160000-004-01084555, Serial Numbers: SR722380103SA, SR722380100SA, SR722380101SA, SR722380102SA; Model Number 6160000-004-01084584, Serial Numbers: SR722360171SA, SR722360168SA, SR722360169SA, SR722360170SA, SR722360172SA; Model Number 6160000-004-01086046, Serial Numbers: SR722380105SA, SR722380104SA; Model Number 6160000-004-01086840, Serial Numbers: SR722370116SA, SR722370113SA, SR722370114SA, SR722370115SA, SR722370117SA, SR722370118SA, SR722370119SA, SR722370120SA, SR722370121SA, SR722370122SA; Model Number 6160000-004-100174, Serial Numbers: SR722230031WA, SR722230044WA, SR722230041WA, SR722230042WA, SR722230043WA, SR722230045WA, SR722230046WA, SR722230047WA, SR722230048WA, SR722230049WA, SR722230050WA, SR722230054WA, SR722230055WA, SR722230056WA, SR722230057WA, SR722230058WA, SR722230059WA, SR722230033WA, SR722230037WA, SR722230034WA, SR722230035WA, SR722230036WA, SR722230038WA, SR722230039WA, SR722230040WA, SR722230032WA, SR722230020WA, SR722230017WA, SR722230018WA, SR722230019WA, SR722230021WA, SR722230022WA, SR722230023WA, SR722230024WA, SR722230025WA, SR722230026WA, SR722230030WA, SR722230027WA, SR722230028WA, SR722230029WA, SR722230007WA, SR722230008WA, SR722230009WA, SR722230010WA, SR722230011WA, SR722230012WA, SR722230013WA, SR722230014WA, SR722230015WA, SR722230016WA; Model Number 6160000-004-100230, Serial Numbers: SR722350105WA, SR722350141WA, SR722350142WA, SR722350143WA, SR722350144WA, SR722360131WA; Model Number 6160000-004-100236, Serial Numbers: SR722180003WA; Model Number 6160000-004-100384, Serial Numbers: SR722360069WA; Model Number 6160000-004-100392, Serial Numbers: SR722180005WA; Model Number 6160000-004-100732, Serial Numbers: SR722350152PA, SR722350073PA, SR722350069PA, SR722350147PA, SR722350151PA, SR722350006PA, SR722370042PA, SR722370050PA, SR722370047PA, SR722370048PA, SR722370049PA, SR722370073PA, SR722370086PA, SR722370087PA, SR722370088PA, SR722370089PA, SR722370090PA, SR722370044PA, SR722370043PA, SR722370046PA, SR722260004PA, SR722310004PA, SR722350008PA, SR722350007PA, SR722270005PA, SR722270002PA, SR722270003PA, SR722270004PA, SR722270007PA, SR722270009PA, SR722270010PA, SR722270011PA, SR722270012PA, SR722270013PA, SR722270014PA, SR722270015PA, SR722270016PA, SR722270019PA, SR722270021PA, SR722270024PA, SR722270032PA, SR722270036PA, SR722280006PA, SR722270039PA, SR722270041PA, SR722280003PA, SR722280008PA, SR722280009PA, SR722280018PA, SR722270022PA, SR722270006PA, SR722270008PA, SR722270020PA, SR722270027PA, SR722270023PA, SR722270025PA, SR722270026PA, SR722270031PA, SR722270033PA, SR722270034PA, SR722270037PA, SR722270035PA, SR722280001PA, SR722270038PA, SR722270040PA, SR722270042PA, SR722280004PA, SR722280005PA, SR722280007PA, SR722280010PA, SR722280011PA, SR722280013PA, SR722280014PA, SR722270030PA, SR722270028PA, SR722280016PA, SR722280002PA, SR722280012PA, SR722280015PA, SR722280017PA, SR722280019PA, SR722280020PA, SR722280021PA, SR722280043PA, SR722350146PA, SR722260010PA, SR722270001PA, SR722260013PA, SR722260014PA, SR722270029PA, SR722350135PA, SR722350136PA, SR722350130PA, SR722350131PA, SR722350134PA, SR722370023PA, SR722370357PA, SR722370051PA, SR722370052PA, SR722370053PA, SR722370354PA, SR722270018PA, SR722310003PA, SR722310002PA, SR722370010PA, SR722370013PA, SR722370351PA, SR722370353PA, SR722370352PA, SR722370054PA, SR722370055PA, SR722370057PA, SR722370059PA, SR722370061PA, SR722370062PA, SR722370072PA, SR722370355PA, SR722350153PA, SR722370002PA, SR722360293PA, SR722360296PA, SR722370001PA, SR722370004PA, SR722370005PA, SR722360298PA, SR722370003PA, SR722350067PA, SR722350124PA, SR722350070PA, SR722350071PA, SR722350075PA, SR722350125PA, SR722350128PA, SR722350074PA, SR722350076PA, SR722350126PA, SR722350127PA, SR722350129PA, SR722350132PA, SR722350133PA, SR722260001PA, SR722260011PA, SR722260012PA, SR722310006PA, SR722260009PA, SR722350037PA, SR722350040PA, SR722350041PA, SR722350064PA, SR722350066PA, SR722350068PA, SR722350072PA, SR722260007PA, SR722260003PA, SR722260006PA, SR722260002PA, SR722350014PA, SR722350031PA, SR722350137PA, SR722350138PA, SR722350139PA, SR722350140PA, SR722350145PA, SR722370008PA, SR722370009PA, SR722310005PA, SR722260008PA, SR722350005PA, SR722370006PA, SR722370007PA; Model Number 6160000-004-100967, Serial Numbers: SR722370262WA; Model Number 6160000-004-100968, Serial Numbers: SR722380029WA, SR722380030WA, SR722380031WA, SR722380032WA, SR722380033WA, SR722380034WA, SR722380035WA, SR722380036WA, SR722380037WA, SR722380038WA; Model Number 6160000-004-101193, Serial Numbers: SR722350001WA, SR722350002WA, SR722350003WA, SR722350016WA, SR722350017WA, SR722350018WA, Model Number 6160000-004-101423, Serial Numbers: SR722350020WA, SR722350021WA, SR722350022WA; Model Number 6160000-004-101471, Serial Numbers: SR722190028WA, SR722190029WA, SR722190030WA, SR722190031WA, SR722190032WA, SR722190033WA, SR722190034WA, SR722190035WA, SR722190036WA, SR722190043WA, SR722190044WA, SR722190045WA; Model Number 6160000-004-101537, Serial Numbers: SR722190048WA, SR722190046WA, SR722190047WA, SR722190037WA; Model Number 6160000-004-101827, Serial Numbers: SR722190042WA; Model Number 6160000-004-101864, Serial Numbers: SR722350375WA, SR722350376WA; Model Number 6160000-004-102242, Serial Numbers: SR722350100WA, SR722350379WA, SR722370239WA, SR722370240WA, SR722370241WA, SR722370242WA, SR722370243WA, SR722370244WA, SR722370245WA, SR722370246WA, SR722370247WA, SR722370248WA, SR722370249WA, SR722370250WA; Model Number 6160000-004-102593, Serial Numbers: SR722370322WA, SR722370323WA; Model Number 6160000-004-102720, Serial Numbers: SR722350396WA, SR722350397WA, SR722350398WA, SR722350399WA, SR722350400WA; Model Number 6160000-004-704370, Serial Numbers: SR720500020WA, SR720500023WA; Model Number 6160000-004-704594, Serial Numbers: SR720500022WA; Model Number 6160000-004-704802, Serial Numbers: SR720500012WA, SR720500013WA, SR720500014WA, SR720500015WA, SR720500016WA, SR720500017WA; Model Number 6160000-004-704822, Serial Numbers: SR720500021WA; Model Number 6160000-004-708140, Serial Numbers: SR720510005WA, SR720510006WA, SR721080039WA, SR721070035WA, SR721070037WA, SR721070038WA, SR721080040WA, SR721110187WA, SR721110188WA, SR721110189WA, SR721080049WA, SR721030022WA, SR721030021WA, SR721110146WA, SR721110147WA, SR721110157WA, SR721110158WA, SR721110160WA, SR721110164WA, SR721110176WA, SR721110179WA, SR721110181WA, SR721110184WA, SR721110185WA, SR721110186WA, SR721110168WA, SR721110165WA, SR721110166WA, SR721110167WA, SR721110169WA, SR721110159WA, SR721110161WA, SR721110162WA, SR721110163WA, SR721110170WA, SR721110171WA, SR721110172WA, SR721110173WA, SR721110174WA, SR721110175WA, SR721110177WA, SR721110178WA, SR721110180WA, SR721110182WA, SR721110183WA, SR721080041WA, SR721080042WA, SR720510011WA, SR720510012WA, SR720510009WA, SR720510010WA, SR721010033WA, SR721010030WA, SR721010031WA, SR721010032WA, SR721010034WA, SR721010035WA, SR721010038WA, SR721010039WA, SR721010037WA, SR721010036WA, SR721010020WA, SR721010015WA, SR721010016WA, SR721010017WA, SR721010018WA, SR721010019WA, SR721010021WA, SR721010022WA, SR721010023WA, SR721010024WA, SR721010025WA, SR721010026WA, SR721010027WA, SR721010028WA, SR721010029WA, SR721010014WA, SR721010001WA, SR721010002WA, SR721010003WA, SR721010004WA, SR721010005WA, SR721010006WA, SR721010007WA, SR721010008WA, SR721010009WA, SR721010010WA, SR721010011WA, SR721010012WA, SR721010013WA, SR721030020WA, SR721070033WA, SR721070034WA, SR720510048WA, SR720510013WA, SR720510046WA, SR720510047WA, SR720510049WA, SR721040054WA, SR721080048WA, SR721070030WA, SR721070031WA, SR721110190WA, SR721110191WA, SR721080043WA, SR721080044WA, SR721030018WA, SR721030015WA, SR721030016WA, SR721030017WA, SR721030019WA, SR721040042WA, SR720470001WA, SR721070036WA, SR721040049WA, SR721040053WA, SR721040050WA, SR721040051WA, SR721040052WA, SR721040037WA, SR721040038WA, SR721040039WA, SR721040040WA, SR721040041WA, SR721040043WA, SR721040044WA, SR721040045WA, SR721040046WA, SR721040047WA, SR721040048WA, SR720510008WA, SR721040034WA, SR721040035WA, SR721080047WA, SR721110153WA, SR721110154WA, SR721110156WA, SR721110155WA, SR720470005WA, SR720470006WA, SR720470007WA, SR720470004WA, SR720470002WA, SR720500027WA, SR720500026WA, SR720500028WA, SR720500029WA, SR720500030WA, SR720500031WA, SR720500040WA, SR720500037WA, SR720500038WA, SR720500039WA, SR720500041WA, SR720500042WA, SR720500043WA, SR720500044WA, SR720500036WA, SR720500033WA, SR720500034WA, SR720500035WA, SR721040036WA, SR721110151WA, SR721110148WA, SR721110149WA, SR721110150WA, SR721110152WA, SR721110193WA, SR721110192WA, SR721080050WA, SR721080051WA, SR721100144WA, SR721030023WA, SR721030024WA, SR721030025WA, SR721030026WA, SR721030027WA, SR721030028WA, SR721030032WA, SR721070032WA, SR720510004WA, SR721100145WA, SR720470003WA, SR721030031WA, SR721030033WA, SR721080046WA, SR721080045WA; Model Number 6160000-004-711345, Serial Numbers: SR720480009WA, SR720480010WA, SR720480012WA, SR720480011WA; Model Number 6160000-004-711346, Serial Numbers: SR720480001WA, SR720480002WA, SR720480003WA, SR720480004WA, SR720480005WA, SR720480006WA, SR720480007WA, SR720480008WA; Model Number 6160000-004-711766, Serial Numbers: SR720500018WA, SR720500019WA; Model Number 6160000-004-711829, Serial Numbers: SR720500032WA; Model Number 6160000-004-721717, Serial Numbers: SR720480016WA, SR720480014WA, SR720480017WA, SR720480013WA, SR720480015WA; Model Number 6160000-004-721877, Serial Numbers: SR720480030WA, SR720480031WA, SR720480032WA, SR720480033WA, SR720480034WA, SR720480035WA, SR720480036WA, SR720480037WA, SR720480038WA, SR720480039WA, SR720480040WA, SR720480041WA, SR720480042WA, SR720480043WA, SR720480044WA, SR720480051WA, SR720480048WA, SR720480049WA, SR720480050WA, SR720480052WA, SR720480045WA, SR720480046WA, SR720480047WA, SR720480058WA, SR720480053WA, SR720480054WA, SR720480055WA, SR720480056WA, SR720480057WA, SR720480059WA, SR720480060WA, SR720480061WA, SR720480062WA, SR720480063WA, SR720480064WA, SR720480065WA, SR720480066WA, SR720480067WA, SR720480068WA, SR720480069WA, SR720480070WA, SR720480071WA, SR720480072WA, SR720480073WA, SR720480074WA, SR720490075WA, SR720490076WA, SR720490085WA, SR720490082WA, SR720490083WA, SR720490084WA, SR720490086WA, SR720490087WA, SR720490088WA, SR720490092WA, SR720490089WA, SR720490090WA, SR720490091WA, SR720490077WA, SR720490078WA, SR720490079WA, SR720490080WA, SR720490081WA; Model Number 6160000-004-721878, Serial Numbers: SR720480018WA, SR720480021WA, SR720480019WA, SR720480020WA, SR720490001WA, SR720500006WA, SR720500001WA, SR720500002WA, SR720500003WA, SR720500004WA, SR720500005WA, SR720500007WA, SR720500008WA, SR720500009WA, SR720500010WA, SR720500011WA; Model Number 6160000-004-721879, Serial Numbers: SR720480022WA, SR720480023WA, SR720480024WA, SR720480025WA, SR720480026WA, SR720480027WA, SR720480028WA, SR720480029WA; Model Number 6160000-004-725540, Serial Numbers: SR721020005WA, SR721020002WA, SR721020003WA, SR721020004WA, SR721020006WA, SR721020007WA, SR721020008WA, SR721020009WA, SR721030003WA, SR721020010WA, SR721030001WA, SR721030002WA, SR721030004WA, SR721030005WA, SR721030006WA, SR721030007WA; Model Number 6160000-004-726234, Serial Numbers: SR720510001WA; Model Number 6160000-004-726235, Serial Numbers: SR720510017WA; Model Number 6160000-004-726239, Serial Numbers: SR720510016WA; Model Number 6160000-004-726249, Serial Numbers: SR720510003WA; Model Number 6160000-004-726250, Serial Numbers: SR720510002WA; Model Number 6160000-004-736312, Serial Numbers: SR721010042WA, SR721010043WA, SR721010044WA, SR721010045WA, SR721010046WA, SR721010047WA, SR721010048WA, SR721030009WA, SR721030010WA, SR721030014WA; Model Number 6160000-004-738741, Serial Numbers: SR721060011WA, SR721060012WA, SR721060013WA, SR721060016WA, SR721040001WA, SR721040002WA, SR721040003WA, SR721040004WA, SR721040005WA, SR721040006WA, SR721040007WA, SR721040008WA, SR721040009WA, SR721040010WA, SR721040022WA, SR721040023WA, SR721040012WA, SR721040013WA, SR721040014WA, SR721040015WA, SR721040016WA, SR721040017WA, SR721040018WA, SR721040019WA, SR721040020WA, SR721040021WA, SR721040024WA, SR721040025WA, SR721040026WA, SR721040027WA, SR721040028WA, SR721040029WA, SR721040030WA, SR721040031WA, SR721040032WA, SR721040033WA, SR721040055WA, SR721040056WA, SR721040057WA, SR721060014WA, SR721060015WA, SR721060017WA; Model Number 6160000-004-739172, Serial Numbers: SR721320179WA, SR721320176WA, SR721320177WA, SR721320178WA, SR721320180WA, SR721320181WA, SR721320182WA, SR721320183WA, SR721320187WA, SR721320184WA, SR721320185WA, SR721320186WA, SR721320188WA, SR721320189WA, SR721320190WA, SR721320191WA, SR721320168WA, SR721320164WA, SR721320165WA, SR721320167WA, SR721320169WA, SR721320170WA, SR721320171WA, SR721320172WA, SR721320173WA, SR721320174WA, SR721320175WA, SR721320163WA, SR721320147WA, SR721320149WA, SR721320151WA, SR721320159WA, SR721320161WA, SR721320152WA, SR721320153WA, SR721320155WA, SR721320156WA, SR721320157WA, SR721320145WA, SR721320142WA, SR721320143WA, SR721320144WA, SR721320146WA, SR721320148WA, SR721320150WA, SR721320154WA, SR721320158WA, SR721320160WA, SR721320162WA, SR721320166WA, SR721100133WA, SR721100129WA, SR721100130WA, SR721100131WA, SR721100132WA; Model Number 6160000-004-754962, Serial Numbers: SR721070005WA, SR721070006WA, SR721070007WA, SR721070008WA, SR721070009WA, SR721070010WA, SR721070011WA, SR721070012WA, SR721070013WA, SR721070014WA, SR721070015WA, SR721070016WA, SR721070017WA, SR721070018WA, SR721070019WA, SR721070020WA, SR721070021WA, SR721070022WA, SR721070023WA, SR721070024WA, SR721070025WA, SR721070026WA, SR721070027WA; Model Number 6160000-004-755184, Serial Numbers: SR721060001WA; Model Number 6160000-004-755218, Serial Numbers: SR721060003WA; Model Number 6160000-004-758039, Serial Numbers: SR721070029WA; Model Number 6160000-004-758040, Serial Numbers: SR721070028WA; Model Number 6160000-004-761768, Serial Numbers: SR721100134WA; Model Number 6160000-004-762113, Serial Numbers: SR721060020WA, SR721060021WA; Model Number 6160000-004-762115, Serial Numbers: SR721060022WA, SR721060023WA, SR721070001WA, SR721070002WA, SR721070003WA, SR721070004WA; Model Number 6160000-004-765446, Serial Numbers: SR721080001WA; Model Number 6160000-004-766544, Serial Numbers: SR721120007WA, SR721120008WA; Model Number 6160000-004-769589, Serial Numbers: SR721110002WA; Model Number 6160000-004-769800, Serial Numbers: SR721100141WA, SR721100139WA, SR721100140WA; Model Number 6160000-004-769819, Serial Numbers: SR721080004WA, SR721080005WA, SR721080006WA, SR721080007WA, SR721080008WA, SR721080009WA, SR721080010WA, SR721080011WA, SR721080012WA, SR721080013WA, SR721080014WA, SR721080015WA, SR721080016WA, SR721080017WA, SR721080018WA, SR721080019WA, SR721080020WA, SR721080021WA, SR721080022WA, SR721080023WA, SR721080024WA, SR721080025WA, SR721080026WA, SR721080027WA, SR721080028WA, SR721080029WA, SR721080030WA, SR721080031WA, SR721090001WA, SR721090002WA, SR721090003WA, SR721090004WA, SR721090005WA, SR721090006WA, SR721090007WA, SR721090008WA, SR721090009WA, SR721090010WA, SR721090011WA, SR721090012WA, SR721090013WA, SR721090014WA, SR721090015WA, SR721090016WA, SR721090017WA, SR721090018WA, SR721090019WA, SR721090020WA, SR721090021WA, SR721090022WA, SR721090023WA, SR721090024WA, SR721090025WA, SR721090026WA, SR721090027WA, SR721090028WA, SR721090029WA, SR721090030WA, SR721090031WA, SR721090032WA, SR721090033WA, SR721090034WA, SR721090035WA, SR721090036WA, SR721090037WA, SR721090038WA, SR721090039WA, SR721090040WA, SR721090041WA, SR721090042WA, SR721090043WA, SR721090044WA, SR721090045WA, SR721090046WA, SR721090047WA, SR721090048WA, SR721090049WA, SR721090050WA, SR721090051WA, SR721090052WA, SR721090053WA, SR721090054WA, SR721090055WA, SR721090056WA, SR721090057WA, SR721090058WA, SR721090059WA, SR721090060WA, SR721090061WA, SR721090062WA, SR721090063WA, SR721090064WA, SR721090065WA, SR721090066WA, SR721090067WA, SR721090068WA, SR721090069WA, SR721090070WA, SR721090071WA, SR721090072WA, SR721100026WA, SR721100027WA, SR721100028WA, SR721100029WA, SR721100030WA, SR721100031WA, SR721100032WA, SR721100033WA, SR721100034WA, SR721100035WA, SR721100036WA, SR721100037WA, SR721100038WA, SR721100039WA, SR721100040WA, SR721100041WA, SR721100042WA, SR721100043WA, SR721100044WA, SR721100045WA, SR721100046WA, SR721100047WA, SR721100048WA, SR721100049WA, SR721100050WA, SR721100051WA, SR721100052WA, SR721100053WA, SR721100054WA, SR721100055WA, SR721100056WA, SR721100057WA, SR721100058WA, SR721100059WA, SR721100060WA, SR721100061WA, SR721100062WA, SR721100063WA, SR721100064WA, SR721100065WA, SR721100066WA, SR721100067WA, SR721100068WA, SR721100069WA, SR721100070WA, SR721100071WA, SR721100072WA, SR721100073WA, SR721100074WA, SR721100075WA, SR721100076WA, SR721100077WA, SR721100078WA, SR721100079WA, SR721100080WA, SR721100081WA, SR721100082WA, SR721100083WA, SR721100084WA, SR721100085WA, SR721100086WA, SR721100087WA, SR721100088WA, SR721100089WA, SR721100090WA, SR721100091WA, SR721100092WA, SR721100093WA, SR721100094WA, SR721100095WA, SR721100096WA, SR721100097WA, SR721100098WA, SR721100099WA, SR721100100WA, SR721100101WA, SR721100102WA, SR721100103WA, SR721100104WA, SR721100105WA, SR721100106WA, SR721100107WA, SR721100108WA, SR721100109WA, SR721100110WA, SR721100111WA, SR721100112WA, SR721100113WA, SR721100114WA, SR721100115WA, SR721100116WA, SR721100117WA, SR721100118WA, SR721100119WA, SR721100120WA, SR721100121WA, SR721100122WA, SR721100123WA, SR721100124WA, SR721100125WA; Model Number 6160000-004-772672, Serial Numbers: SR721080003WA, SR721080002WA; Model Number 6160000-004-774514, Serial Numbers: SR721100135WA, SR721100136WA, SR721100137WA, SR721100138WA; Model Number 6160000-004-774647, Serial Numbers: SR721100126WA, SR721120005WA; Model Number 6160000-004-777242, Serial Numbers: SR721100127WA, SR721370031WA, SR721370030WA; Model Number 6160000-004-778745, Serial Numbers: SR721110001WA; Model Number 6160000-004-778871, Serial Numbers: SR721100142WA, SR721100143WA; Model Number 6160000-004-781927, Serial Numbers: SR721110004WA, SR721110003WA; Model Number 6160000-004-783851, Serial Numbers: SR721120006WA, SR721140056WA, SR721140057WA, SR721140058WA, SR721140059WA, SR721140060WA, SR721140061WA, SR721210072WA, SR721230008WA, SR721430027WA, SR721430074WA, SR721430062WA, SR721430063WA, SR721430064WA, SR721430065WA, SR721430066WA, SR721430075WA, SR721430076WA, SR721430077WA, SR721430078WA, SR721430079WA, SR721430082WA, SR721430083WA, SR721430084WA, SR721430085WA, SR721430086WA, SR721430087WA, SR721430088WA, SR721430089WA, SR721430090WA, SR721430091WA, SR721430092WA, SR721430093WA, SR721430094WA, SR721430095WA, SR721430096WA, SR721430097WA, SR721430098WA, SR721430099WA, SR721430100WA, SR722320128WA, SR722320120WA, SR722320122WA, SR722320125WA, SR722320129WA, SR722320130WA, SR722320131WA, SR722320135WA, SR722320138WA, SR722320141WA, SR722320149WA, SR722320158WA, SR722320121WA, SR722320123WA, SR722320124WA, SR722320126WA, SR722320127WA, SR722320132WA, SR722320133WA, SR722320134WA, SR722320136WA, SR722320137WA, SR722320139WA, SR722320144WA, SR722320140WA, SR722320142WA, SR722320143WA, SR722320145WA, SR722320146WA, SR722320147WA, SR722320148WA, SR722320150WA, SR722320151WA, SR722320152WA, SR722320153WA, SR722320157WA, SR722320154WA, SR722320155WA, SR722320156WA, SR722320159WA, SR722320160WA, SR722320161WA, SR722320162WA; Model Number 6160000-004-783940, Serial Numbers: SR721120009WA; Model Number 6160000-004-787855, Serial Numbers: SR721200117WA, SR721200118WA, SR721490038WA, SR721330156WA, SR721330157WA, SR721330158WA, SR721240016WA, SR721190088WA, SR721190090WA, SR721330166WA, SR721330167WA, SR721330168WA, SR721330164WA, SR721330165WA, SR721490039WA, SR721490040WA, SR721490041WA, SR721490112WA, SR721490092WA, SR721490093WA, SR721200120WA, SR721200121WA, SR721200122WA, SR721200123WA, SR721200124WA, SR721330185WA, SR721190084WA, SR721190047WA, SR721480034WA, SR721480031WA, SR721480032WA, SR721480033WA, SR721480022WA, SR721480023WA, SR721480024WA, SR721480025WA, SR721480026WA, SR721480027WA, SR721480028WA, SR721480029WA, SR721480030WA, SR721480042WA, SR721480036WA, SR721480064WA, SR721490091WA, SR721190101WA, SR721330149WA, SR721480060WA, SR721280057WA, SR721490090WA, SR721330188WA, SR721480045WA, SR721480048WA, SR721480049WA, SR721480050WA, SR721480051WA, SR721480052WA, SR721480053WA, SR721480054WA, SR721480055WA, SR721480056WA, SR721480057WA, SR721480061WA, SR721480062WA, SR721480059WA, SR721240048WA, SR721330151WA, SR721330152WA, SR721330153WA, SR721330154WA, SR721330155WA, SR721190037WA, SR721190041WA, SR721190038WA, SR721190039WA, SR721190040WA, SR721190042WA, SR721190043WA, SR721190044WA, SR721190045WA, SR721190046WA, SR721490089WA, SR721480020WA, SR721480021WA, SR721330183WA, SR721200014WA, SR721200013WA, SR721200015WA, SR721330189WA, SR721490029WA, SR721490030WA, SR721330190WA, SR721330191WA, SR721150040WA, SR721490027WA, SR721190085WA, SR721190086WA, SR721280064WA, SR721280065WA, SR721200011WA, SR721200012WA, SR721490028WA, SR721380024WA, SR721380021WA, SR721380022WA, SR721380023WA, SR721380025WA, SR721380026WA, SR721380027WA, SR721380028WA, SR721380029WA, SR721380030WA, SR721380031WA, SR721380033WA, SR721380034WA, SR721380035WA, SR721380037WA, SR721380038WA, SR721380039WA, SR721380041WA, SR721380042WA, SR721380043WA, SR721380045WA, SR721380046WA, SR721380013WA, SR721380012WA, SR721380014WA, SR721380016WA, SR721380017WA, SR721380018WA, SR721380019WA, SR721380020WA, SR721190092WA, SR721190093WA, SR721190094WA, SR721240020WA, SR721240021WA, SR721240022WA, SR721240017WA, SR721240018WA, SR721240019WA, SR721490087WA, SR721490088WA, SR721330159WA, SR721480043WA, SR721490036WA, SR721380015WA, SR721330178WA, SR721380040WA, SR721190014WA, SR721380032WA, SR721330160WA, SR721380044WA, SR721190016WA, SR721190021WA, SR721190018WA, SR721190019WA, SR721190020WA, SR721190022WA, SR721190023WA, SR721190024WA, SR721190025WA, SR721190026WA, SR721190027WA, SR721190028WA, SR721190029WA, SR721190030WA, SR721190031WA, SR721190032WA, SR721190033WA, SR721190034WA, SR721190035WA, SR721190036WA, SR721190017WA, SR721280062WA, SR721280063WA, SR721320138WA, SR721320130WA, SR721320134WA, SR721320131WA, SR721320132WA, SR721320133WA, SR721320135WA, SR721320136WA, SR721320137WA, SR721320139WA, SR721320140WA, SR721320141WA, SR721480044WA, SR721140044WA, SR721140042WA, SR721140043WA, SR721140045WA, SR721140046WA, SR721140047WA, SR721140048WA, SR721490037WA, SR721200125WA, SR721200126WA, SR721200127WA, SR721200128WA, SR721200129WA, SR721200130WA, SR721200131WA, SR721200132WA, SR721200133WA, SR721200134WA, SR721240012WA, SR721240009WA, SR721240010WA, SR721240011WA, SR721240013WA, SR721240014WA, SR721240015WA, SR721240004WA, SR721240001WA, SR721240002WA, SR721240003WA, SR721240005WA, SR721240006WA, SR721240007WA, SR721240008WA, SR721190013WA, SR721190015WA, SR721330176WA, SR721330148WA, SR721330162WA, SR721240050WA, SR721280018WA, SR721480063WA, SR721280059WA, SR721190057WA, SR721190054WA, SR721190055WA, SR721190056WA, SR721190063WA, SR721190058WA, SR721190059WA, SR721190060WA, SR721190061WA, SR721190062WA, SR721190064WA, SR721190065WA, SR721190066WA, SR721190067WA, SR721150033WA, SR721190111WA, SR721190087WA, SR721490043WA, SR721490050WA, SR721150048WA, SR721190103WA, SR721190104WA, SR721190105WA, SR721190106WA, SR721190107WA, SR721190109WA, SR721190110WA, SR721200016WA, SR721200017WA, SR721200018WA, SR721200009WA, SR721200010WA, SR721240023WA, SR721240024WA, SR721330147WA, SR721330150WA, SR721480046WA, SR721480047WA, SR721490051WA, SR721490052WA, SR721490053WA, SR721280066WA, SR721280067WA, SR721330142WA, SR721330143WA, SR721330144WA, SR721330145WA, SR721330146WA, SR721490054WA, SR721490055WA, SR721490056WA, SR721490064WA, SR721490061WA, SR721490062WA, SR721490063WA, SR721490065WA, SR721490060WA, SR721490057WA, SR721490058WA, SR721490059WA, SR721480039WA, SR721480040WA, SR721480041WA, SR721150047WA, SR721190076WA, SR721190077WA, SR721190078WA, SR721190079WA, SR721190080WA, SR721190081WA, SR721190082WA, SR721190083WA, SR721190089WA, SR721240027WA, SR721330187WA, SR721380010WA, SR721490032WA, SR721490033WA, SR721330161WA, SR721490111WA, SR721200114WA, SR721200115WA, SR721200023WA, SR721200024WA, SR721200004WA, SR721200005WA, SR721200006WA, SR721200007WA, SR721200008WA, SR721490031WA, SR721150027WA, SR721150023WA, SR721150024WA, SR721150025WA, SR721150026WA, SR721330170WA, SR721330171WA, SR721330172WA, SR721330163WA, SR721190102WA, SR721140018WA, SR721140017WA, SR721140019WA, SR721140020WA, SR721140021WA, SR721140022WA, SR721140023WA, SR721140024WA, SR721140025WA, SR721140026WA, SR721140027WA, SR721140028WA, SR721140029WA, SR721140030WA, SR721140034WA, SR721140031WA, SR721140032WA, SR721140033WA, SR721140035WA, SR721140036WA, SR721190112WA, SR721190113WA, SR721240049WA, SR721150050WA, SR721150049WA, SR721190011WA, SR721190008WA, SR721190009WA, SR721190010WA, SR721

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0732-2023
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.