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RecallWatchMedical Device Safety
Class IIOngoingZ-0454-2026

GE Healthcare Finland Oy recalls CARESCAPE ONE

GE Healthcare Finland OyHelsinki, FinlandReported Nov 19, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001

Lot / code information

UDI
00195278288639
Serial #
SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA SV92…Show all
SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA SV925080340SA SV925080281SA SV925080346SA SV925290119SA SV925290090SA SV925180134SA SV925160111SA SV925180131SA SV925180139SA SV925180140SA SV925180142SA SV925180143SA SV925180151SA SV925180152SA SV925160114SA SV925180141SA SV925180126SA SV925180132SA SV925180136SA SV925180135SA SV925180144SA SV925180146SA SV925180149SA SV925270007SA SV925260094SA SV925270009SA SV925270010SA SV925270008SA SV925260111SA SV925270003SA SV925270011SA SV925260085SA SV925260113SA SV925270001SA SV925270002SA SV925270006SA SV925270012SA SV925270005SA SV925270004SA SV925190002SA SV925180193SA SV925100151SA SV925100149SA SNA24400063SA SV925190009SA SV925200017SA SV925200028SA SV925190021SA SV925200022SA SV925200008SA SV925200015SA SV925200016SA SV925200021SA SV925200023SA SV925190014SA SV925200013SA SV925200012SA SV925200018SA SNA24162829SA SV925290115SA SV925220285SA SV925220291SA SV925220275SA SV925220267SA SV925220311SA SV925220240SA SV925220280SA SV925210129SA SV925220304SA SV925220255SA SV925220273SA SV925220288SA SV925210198SA SV925220281SA SV925220295SA SV925210171SA SV925220241SA SV925220290SA SV925210156SA SV925210165SA SV925210164SA SV925210163SA SV925210168SA SV925210137SA SV925210131SA SV925210141SA SV925190017SA SV925210136SA SV925210152SA SV925210162SA SV925210135SA SV925210149SA SV925210146SA SV925210126SA SV925210088SA SV925210139SA SV925150104SA SV925210158SA SV925060273SA SV925210145SA SV925210114SA SV925210166SA SV925220233SA SV925210115SA SV925210144SA SV925210153SA SV925210147SA SV925220262SA SV925220248SA SV925200025SA SV925220251SA SV925220282SA SV925220279SA SV925220246SA SV925220252SA SV925220284SA SV925210155SA SV925220254SA SV925220258SA SV925220274SA SV925220283SA SV925220287SA SV925220245SA SV925220242SA SV925220289SA SV925220272SA SV925220277SA SV925220230SA SV925220297SA SV925220302SA SV925220243SA SV925200003SA SV925220296SA SV925220286SA SV925220294SA SV925210161SA SV925220301SA SV925220307SA SV925220303SA SV925210142SA SV925180108SA SV925210132SA SV925210143SA SV925210138SA SV925210159SA SV925210151SA SV925210209SA SV925220308SA SV925220300SA SV925220278SA SV925190028SA SV925210085SA SV925210157SA SV925210148SA SV925210170SA SV925210134SA SV925220249SA SV925210128SA SV925220253SA SV925210172SA SV925210140SA SV925220247SA SV925210212SA SV925210154SA SV925210112SA SV925280116SA SV925060120SA SV925060122SA SV925060387SA SV925100103SA SV925090177SA SNA24500251SA SNA24122280SA SNA24400026SA SNA24500223SA SNA24480069SA SV925110015SA SV925120021SA SV925100200SA SV925110116SA SV925090084SA SV925110117SA SV925110033SA SV925100106SA SV925110018SA SNA24510039SA SNA24122279SA SNA24122309SA SV925110062SA SNA24400025SA SV925220306SA SV925230434SA SV925230517SA SV925230512SA SV925230471SA SV925230520SA SV925230509SA SV925230514SA SV925230441SA SV925230544SA SV925230524SA SV925230425SA SV925230543SA SV925230511SA SV925230554SA SV925230495SA SV925230519SA SV925230535SA SV925230540SA SV925230529SA SV925230510SA SV925230508SA SV925230491SA SV925230473SA SV925230547SA SV925230527SA SV925230537SA SV925230523SA SV925230507SA SV925230463SA SV925230557SA SV925230536SA SV925230539SA SV925230477SA SV925230553SA SV925230493SA SV925230559SA SV925200048SA SV925230501SA SV925230465SA SV925200070SA SV925200052SA SV925230468SA SV925230515SA SV925230467SA SV925230538SA SV925230552SA SV925230541SA SV925230505SA SV925230448SA SV925230521SA SV925230504SA SV925230546SA SV925230545SA SV925230518SA SV925230499SA SV925230502SA SV925230556SA SV925230475SA SV925230530SA SV925230464SA SV925230470SA SV925230551SA SV925230380SA SV925220325SA SV925230479SA SV925230526SA SV925230513SA SV925230500SA SV925230542SA SV925230474SA SV925230498SA SV925230496SA SV925230522SA SV925230430SA SV925230558SA SV925220330SA SV925200072SA SV925100204SA SV925150091SA SV925150092SA SV925110028SA SV925110035SA SV925150095SA SV925150094SA SV925150107SA SV925150096SA SV925100210SA SV925060390SA SV925200046SA SV925230610SA SV925240626SA SV925240635SA SV925240633SA SV925240638SA SV925240625SA SV925090164SA SV925090176SA SV925090179SA SV925090145SA SV925090113SA SV925090167SA SV925100013SA SV925100010SA SV925180052SA SV925180053SA SV925180159SA SV925180059SA SV925180148SA SV925170019SA SV925180072SA SV925160024SA SV925230478SA SV925230480SA SV925080016SA SV925080012SA SV925080006SA SV925080011SA SV925070515SA SV925080022SA SV925080013SA SV925080025SA SV925100088SA SV925100154SA SV925100093SA SV925100074SA SV925100165SA SV925100052SA SV925100102SA SV925100166SA SV925100140SA SV925240876SA SV925240806SA SV925250104SA SV925250081SA SV925240808SA SV925240905SA SV925240907SA SV925240887SA SV925250114SA SV925240798SA SV925250118SA SV925250102SA SV925270232SA SV925270171SA SV925250112SA SV925250115SA SV925250095SA SV925250093SA SV925250111SA SV925120038SA SV925120026SA SV925120054SA SV925120007SA SV925120014SA SV925120048SA SV925110037SA SV925120069SA SV925120013SA SV925120039SA SV925120049SA SV925120047SA SV925120035SA SV925120079SA SV925230617SA SV925240624SA SV925230611SA SV925230621SA SV925230614SA SV925230613SA SV925230612SA SV925230615SA SV925230620SA SV925230609SA SV925230616SA SV925230619SA SV925240623SA SV925300011SA SNA25040004SA SV925080339SA SV925080347SA SV925080319SA SV925080280SA SV925080244SA SV925080311SA SV925090106SA SV925090087SA SV925170002SA SV925180002SA SV925160109SA SV925170012SA SV925180015SA SV925170027SA SV925170009SA SV925170001SA SV925170024SA SV925180008SA SV925170020SA SV925170016SA SV925200042SA SV925260087SA SV925260068SA SV925090121SA SV925090125SA SV925090122SA SV925090123SA SV925090124SA SV925090126SA SV925270147SA SV925270154SA SV925270156SA SV925270143SA SV925270148SA SV925270118SA SV925270234SA SV925270151SA SV925270159SA SV925270142SA SV925270170SA SV925270152SA SV925270160SA SV925270146SA SV925270229SA SV925270145SA SV925270 …
Additional code information

A SV925070457SA SV925110025SA SV925110041SA SV925110046SA SV925110021SA SV925100153SA SV925280124SA SV925100196SA SV925100191SA SV925100174SA SV925100183SA SV925100113SA SV925100198SA SV925080162SA SV925080161SA SV925080364SA SV925080362SA SV925080377SA SV925080369SA SV925080375SA SV925070432SA SV925090024SA SV925080379SA SV925080392SA SV925090034SA SV925080401SA SV925090002SA SV925090027SA SV925090030SA SV925090033SA SV925080400SA SV925080110SA SV925080365SA SV925080373SA SV925090038SA SV925090016SA SV925090021SA SV925080367SA SV925080384SA SV925080355SA SV925080378SA SV925080381SA SV925080371SA SV925080396SA SV925080399SA SV925090007SA SV925080389SA SV925080388SA SV925080368SA SV925090009SA SV925090032SA SV925080393SA SV925080366SA SV925090017SA SV925080398SA SV925080370SA SV925090042SA SV925090039SA SV925090036SA SV925080383SA SV925080385SA SV925080382SA SV925070147SA SV925090028SA SV925080387SA SV925090006SA SV925090014SA SV925090018SA SV925090037SA SV925090015SA SV925090023SA SV925080390SA SV925090044SA SV925090046SA SV925090045SA SV925210205SA SV925210187SA SV925210211SA SV925220225SA SV925220232SA SV925210173SA SV925210199SA SV925210177SA SV925210175SA SV925220221SA SV925180158SA SV925220222SA SV925210160SA SV925210191SA SV925210195SA SV925210193SA SV925210188SA SV925210169SA SV925210178SA SV925210174SA SV925200024SA SV925190050SA SV925210176SA SV925210202SA SV925180107SA SV925210196SA SV925210192SA SV925210207SA SV925210185SA SV925210183SA SV925210203SA SV925210181SA SV925200065SA SV925210200SA SV925210190SA SV925220224SA SV925210197SA SV925210204SA SV925210180SA SV925210201SA SV925210182SA SV925220223SA SV925210208SA SV925220226SA SV925220229SA SV925060081SA SV925220216SA SV925220219SA SV925220231SA SV925220234SA SV925220228SA SV925210179SA SV925210194SA SV925220215SA SV925210150SA SV925220227SA SV925210184SA SV925210189SA SV925210206SA SV925210186SA SV925240847SA SV925240864SA SV925240820SA SV925240818SA SV925240816SA SV925240866SA SV925240833SA SV925240829SA SV925240821SA SV925240815SA SV925240854SA SV925240828SA SV925240834SA SV925240813SA SV925240803SA SV925240790SA SV925240795SA SV925240853SA SV925240835SA SV925240802SA SV925240842SA SV925240799SA SV925240804SA SV925240856SA SV925240861SA SV925240801SA SV925240838SA SV925240877SA SV925240809SA SV925240844SA SV925240823SA SV925240870SA SV925240822SA SV925240875SA SV925240841SA SV925240837SA SV925240852SA SV925240839SA SV925240845SA SV925240863SA SV925240855SA SV925240862SA SV925240819SA SV925240850SA SV925240824SA SV925240825SA SV925240826SA SV925240868SA SV925240857SA SV925240811SA SV925240810SA SV925240831SA SV925240807SA SV925240851SA SV925240817SA SV925240849SA SV925240827SA SV925240836SA SV925240800SA SV925240782SA SV925240832SA SV925240814SA SV925240848SA SV925240867SA SV925240859SA SV925240865SA SV925240805SA SV925270061SA SV925270062SA SV925270069SA SV925270067SA SV925060050SA SV925060049SA SV925060048SA SV925050108SA SV925050064SA SV925060057SA SV925040013SA SV925050142SA SV925060053SA SV925050134SA SV925060046SA SV925050043SA SV925050117SA SV925050035SA SV925050136SA SV925050183SA SV925050106SA SV925050135SA SV925040011SA SV925050204SA SV925050006SA SV925050158SA SV925050013SA SV925050125SA SV925050139SA SV925050004SA SV925050119SA SV925050159SA SV925050160SA SV925050010SA SV925050138SA SV925050127SA SV925050140SA SV925050096SA SV925050031SA SV925050145SA SV925050028SA SV925050147SA SV925050181SA SV925050075SA SV925050011SA SV925050002SA SV925050157SA SV925040014SA SV925040018SA SV925050132SA SV925050104SA SV925050206SA SV925050168SA SV925050046SA SV925050152SA SV925050054SA SV925050144SA SV925050053SA SV925050040SA SV925050005SA SV925050201SA SV925050146SA SV925050061SA SV925050099SA SV925050033SA SV925050150SA SV925050036SA SV925050163SA SV925050149SA SV925050174SA SV925050026SA SV925050029SA SV925050115SA SV925050095SA SV925050121SA SV925050110SA SV925050120SA SV925050109SA SV925050111SA SV925050037SA SV925050129SA SV925050107SA SV925050112SA SV925040017SA SV925050179SA SV925050038SA SV925050020SA SV925050016SA SV925050186SA SV925040016SA SV925050137SA SV925050153SA SV925050118SA SV925050001SA SV925050131SA SV925050103SA SV925050105SA SV925050141SA SV925050122SA SV925050143SA SV925050113SA SV925050114SA SV925050072SA SV925050172SA SV925050170SA SV925050178SA SV925050084SA SV925050187SA SV925050148SA SV925050200SA SV925040015SA SV925050128SA SV925040012SA SV925040020SA SV925050056SA SV925050082SA SV925050022SA SV925050062SA SV925050196SA SV925050154SA SV925050015SA SV925050133SA SV925050126SA SV925050073SA SV925050063SA SV925050039SA SV925050116SA SV925040019SA SV925050212SA SV925050058SA SV925060047SA SV925050017SA SV925050180SA SV925060044SA SV925050220SA SV925050185SA SV925050213SA SV925060007SA SV925060012SA SV925050224SA SV925050156SA SV925050203SA SV925060067SA SV925050182SA SV925060061SA SV925060056SA SV925050166SA SV925050226SA SV925060013SA SV925050177SA SV925060064SA SV925060035SA SV925060005SA SV925050024SA SV925070106SA SV925060458SA SV925070098SA SV925070101SA SV925070099SA SV925070081SA SV925070051SA SV925070087SA SV925070082SA SV925070104SA SV925070105SA SV925070095SA SV925070088SA SV925070100SA SV925070092SA SV925070102SA SV925070093SA SV925070096SA SV925080185SA SV925080192SA SV925080166SA SV925080173SA SV925080156SA SV925080163SA SV925080165SA SV925080188SA SV925080089SA SV925080205SA SV925080074SA SV925080134SA SV925080135SA SV925080129SA SV925080178SA SV925080171SA SV925080179SA SV925080186SA SV925080122SA SV925080131SA SV925080201SA SV925080118SA SV925080150SA SV925080176SA SV925080180SA SV925080158SA SV925080196SA SV925080168SA SV925080190SA SV925080195SA SV925080132SA SV925080207SA SV925080197SA SV925080145SA SV925080140SA SV925080189SA SV925080160SA SV925080130SA SV925080102SA SV925080147SA SV925080193SA SV925080177SA SV925080136SA SV925080172SA SV925080200SA SV925080199SA SV925230456SA SV925250176SA SV925280078SA SV925280058SA SV925280017SA SV925280013SA SV925280052SA SV925280034SA SV925280060SA SV925280035SA SV925280037SA SV925280068SA SV925280069SA SV925280006SA SV925280066SA SV925280054SA SV925280010SA SV925280038SA SV925280009SA SV925270256SA SV925080154SA SV925080202SA SV925080157SA SV925080175SA SV925080181SA SV925080184SA SV925080169SA SV925080167SA SV925080182SA SV925080159SA SV925080170SA SV925080194SA SV925080183SA SV925080187SA SV925080151SA SV925080149SA SV925170022SA SV925160087SA SV925180056SA SV925160082SA SV925120001SA SV925180102SA SV925230469SA SV925260098SA SV925190007SA SV925190012SA SV925180177SA SV925190020SA SV925190015SA SV925190006SA SV925190010SA SV925190013SA SV925180195SA SV925180180SA SV925190003SA SV925180178SA SV925180196SA SV925190008SA SV925120002SA SV925120004SA SV925110083SA SV925120005SA SV925230485SA SV925230487SA SV925230482SA SV925230489SA SV925150002SA SV925110016SA SV925140001SA SV925150001SA SV925140011SA SV925150030SA SV925110039SA SV925150035SA SV925140004SA SV925140012SA SV925150004SA SV925150034SA SV925150031SA SV925110001SA SV925150036SA SV925110081SA SV925140008SA SV925150032SA SV925150039SA SV925150033SA SV925060395SA SV925050051SA SV925050048SA SV925050042SA SV925050049SA SV925050057SA SV925050044SA SV925050045SA SV925050041SA SV925050050SA SV925050055SA SV925050059SA SV925050052SA SV925090052SA SV925090071SA SV925090059SA SV925090048SA SV925090056SA SV925090063SA SV925090068SA SV925090072SA SV925090074SA SV925090073SA SV925090081SA SV925090057SA SV925090055SA SV925090067SA SV925080146SA SV925080376SA SV925080380SA SV925120008SA SV925120096SA SV925080121SA SV925080127SA SV925080120SA SV925070413SA SV925080125SA SV925080116SA SV925080119SA SV925070481SA SV925080126SA SV925080115SA SV925080123SA SV925080124SA SV925080114SA SV925080128SA SV925080117SA SV925080063SA SV925270237SA SV925270251SA SV925280022SA SV925270245SA SV925270150SA SV925280007SA SV925280014SA SV925080103SA SV925080113SA SV925080094SA SV925080099SA SV925100141SA SV925100211SA SV925110007SA SV925100186SA SV925110014SA SV925110105SA SV925110011SA SV925100212SA SV925100209SA SV925110023SA SV925100206SA SV925110003SA SV925100158SA SV925170010SA SV925180013SA SV925180097SA SV925180110SA SV925180128SA SV925180120SA SV925180123SA SV925180098SA SV925180125SA SV925180093SA SV925180106SA SV925150183SA SV925180127SA SV925180099SA SV925180089SA SV925180118SA SNA24400062SA SV925180115SA SV925180112SA SV925180114SA SV925180119SA SV925180122SA SV925180116SA SV925180129SA SV925180100SA SV925180101SA SV925180124SA SV925170018SA SV925180117SA SV925180113SA SV925270068SA SV925100129SA SV925100117SA SV925150088SA SV925110026SA SV925100063SA SV925150082SA SV925150086SA SV925150087SA SV925150089SA SV925150108SA SV925150083SA SV925110019SA SV925150057SA SV925150084SA SV925090117SA SV925260054SA SV925110043SA SV925220342SA SV925150129SA SV925080343SA SV925080331SA SV925080349SA SV925080341SA SV925080336SA SV925080326SA SV925080325SA SV925080332SA SV925080350SA SV925080337SA SV925080333SA SV925080328SA SV925080351SA SV925080334SA SV925080342SA SV925080330SA SV925180019SA SV925070449SA SV925160112SA SV925170035SA SV925170043SA SV925180078SA SV925180058SA SV925180079SA SV925180092SA SV925170040SA SV925160037SA SV925160107SA SV925170031SA SV925180086SA SV925160108SA SV925110110SA SV925180083SA SV925170003SA SV925180057SA SV925180018SA SV925110114SA SV925160006SA SV925180096SA SV925170049SA SV925160121SA SV925180075SA SV925180091SA SNA24400064SA SV925180077SA SV925070441SA SV925060414SA SV925160056SA SV925160071SA SV925160059SA SV925180065SA SV925160130SA SV925070446SA SNA24400066SA SNA24400034SA SV925160106SA SV925180088SA SV925180103SA SV925160128SA SNA24400067SA SV925170036SA SV925070454SA SV925180084SA SV925180080SA SV925170037SA SV925170006SA SV925180090SA SV925170028SA SV925180087SA SV925180076SA SV925180085SA SV925180095SA SV925180105SA SNA24400065SA SV925160127SA SV925180031SA SV925160122SA SV925150123SA SV925170041SA SV925180104SA SV925110109SA SV925160126SA SV925160124SA SV925170029SA SV925160125SA SV925070452SA SV925180082SA SV925150079SA SV925150067SA SV925150076SA SV925150075SA SV925150054SA SV925150080SA SV925150069SA SV925150081SA SV925150071SA SV925150078SA SV925150068SA SV925150072SA SV925150051SA SV925150074SA SV925150073SA SV925150070SA SV925080300SA SV925070364SA SV925070339SA SV925070368SA SV925070230SA SV925070242SA SV925070244SA SV925070264SA SV925060099SA SV925070247SA SV925060299SA SV925070277SA SV925070331SA SV925070346SA SV925070355SA SV925070262SA SV925070263SA SV925070269SA SV925070273SA SV925070251SA SV925070250SA SV925070266SA SV925070253SA SV925060400SA SV925070260SA SV925070133SA SV925070256SA SV925070265SA SV925070258SA SV925070248SA SV925070272SA SV925070332SA SV925070353SA SV925070362SA SV925070374SA SV925070270SA SV925070327SA SV925070336SA SV925070212SA SV925070134SA SV925070341SA SV925070257SA SV925070369SA SV925070375SA SV925070276SA SV925070280SA SV925070330SA SV925070348SA SV925070246SA SV925070338SA SV925070354SA SV925070358SA SV925070337SA SV925070342SA SV925070385SA SV925070245SA SV925070243SA SV925070254SA SV925070259SA SV925070268SA SV925070249SA SV925070340SA SV925070333SA SV925070366SA SV925070351SA SV925070357SA SV925070361SA SV925070372SA SV925070267SA SV925070097SA SV925070378SA SV925070344SA SV925070349SA SV925070252SA SV925070255SA SV925070356SA SV925070367SA SV925070363SA SV925070261SA SV925070206SA SV925070380SA SV925070347SA SV925070334SA SV925070328SA SV925070335SA SV925070359SA SV925280106SA SV925280008SA SV925280062SA SV925280020SA SV925280045SA SV925280097SA SV925280091SA SV925280095SA SV925280039SA SV925280099SA SV925280033SA SV925280100SA SV925280094SA SV925070438SA SV925120036SA SV925070226SA SV925070232SA SV925070234SA SV925070321SA SV925070271SA SV925070289SA SV925070197SA SV925070310SA SV925070071SA SV925070083SA SV925070311SA SV925070318SA SV925070217SA SV925070236SA SV925070231SA SV925070238SA SV925070110SA SV925070227SA SV925070203SA SV925070224SA SV925070196SA SV925070061SA SV925070219SA SV925070225SA SV925070007SA …

What the firm is doing

On September 26, 2025, the recalling firm began notifying affected customers. A second letter was issued on October 3, 2025 which addressed a correction to Affected Product Details information. The customer letter advised users to use a monitor with a battery that is not within the affected battery population. However, pending correction by GE HealthCare, users may continue to use a monitor with affected batteries by following instructions included in the letter. These instructions include having mains power connected whenever possible, confirming appropriate battery status prior to use, and being aware that the monitor may still shut down during patient transport. Users are advised to be prepared to provide alternate methods of assessing the clinical status of the patient, bring a mains power cord during patient transport, and bring a spare battery. GE HealthCare will correct all affected products at no cost to the customer. A GE HealthCare representative will contact each customer to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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