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U.S. Department of Health and Human Services

Class 2 Device Recall Portrait VSM

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 Class 2 Device Recall Portrait VSMsee related information
Date Initiated by FirmSeptember 26, 2025
Date PostedNovember 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0456-2026
Recall Event ID 97786
510(K)NumberK233810 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductPortrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Code Information UDI-DI 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA SWP25130724SA SWP25130725SA SWP25130726SA SWP25130727SA SWP25130728SA SWP25130729SA SWP25130730SA SWP25130731SA SWP25130732SA SWP25130733SA SWP25130734SA SWP25130735SA SWP25130736SA SWP25130737SA SWP25130738SA SWP25130739SA SWP25130740SA SWP25130741SA SWP25230019SA SWP25230020SA SWP25230021SA SWP25230022SA SWP25230026SA SWP25210083SA SWP25210084SA SWP25130751SA SWP25130752SA SWP25130753SA SWP25170019SA SWP25170020SA SWP25170021SA SWP25170022SA SWP25170023SA SWP25170024SA SWP25200033SA SWP25200034SA SWP25200035SA SWP25160027SA SWP25180121SA SWP25180122SA SWP25180123SA SWP25230034SA SWP25230035SA SWP25230036SA SWP25250032SA SWP25250033SA SWP25290061SA SWP25260114SA SWP25260115SA SWP25260116SA SWP25260117SA SWP25250046SA SWP25250047SA SWP25250048SA SWP25250050SA SWP25240013SA SWP25120633SA SWP25130746SA SWP25170056SA SWP25250034SA SWP25290065SA SWP25051286SA SWP25110533SA SWP25190088SA SWP25210044SA SWP25260155SA SWP25260156SA SWP25260157SA SWP25260158SA SWP25120623SA SWP25120627SA SWP25130766SA SWP25130843SA SWP25130844SA SWP25151063SA SWP25151071SA SWP25151087SA SWP25170027SA SWP25170028SA SWP25290048SA SWP25290053SA SWP25110399SA SWP25151065SA SWP25180130SA SWP25260120SA SWP25151070SA SWP25180126SA SWP25180127SA SWP25220010SA SWP25300001SA SWP25300002SA SWP25300003SA SWP25300004SA SWP25300005SA SWP25300006SA SWP25300007SA SWP25300008SA SWP25210078SA SWP25220050SA SWP25190090SA SWP25190091SA SWP25190092SA SWP25220063SA SWP25120626SA SWP25210082SA SWP25110389SA SWP25110390SA SWP25120616SA SWP25120617SA SWP25130744SA SWP25130745SA SWP25160028SA SWP25180128SA SWP25220023SA SWP25220024SA SWP25220025SA SWP25220026SA SWP25220027SA SWP25220028SA SWP25220029SA SWP25220030SA SWP25220031SA SWP25220032SA SWP25220034SA SWP25220035SA SWP25220036SA SWP25220037SA SWP25220038SA SWP25220039SA SWP25220040SA SWP25220041SA SWP25220042SA SWP25220043SA SWP25220044SA SWP25220046SA SWP25220047SA SWP25220048SA SWP25220067SA SWP25270075SA SWP25270076SA SWP25130749SA SWP25130750SA SWP25051387SA SWP25051388SA SWP25051389SA SWP25051390SA SWP25090172SA SWP25090173SA SWP25141031SA SWP25141032SA SWP25220018SA SWP25220019SA SWP25220020SA SWP25280039SA SWP25280040SA SWP25200030SA SWP25200031SA SWP25200032SA SWP25090190SA SWP25090191SA SWP25090192SA SWP25090193SA SWP25100013SA SWP25170048SA SWP25250021SA SWP25250022SA SWP25040958SA SWP25040959SA SWP25200017SA SWP25200018SA SWP25200019SA SWP25200020SA SWP25200021SA SWP25200022SA SWP25051391SA SWP25120622SA SWP25230059SA SWP25230060SA SWP25270073SA SWP25280001SA SWP25280002SA SWP25280003SA SWP25280004SA SWP25280005SA SWP25280006SA SWP25280007SA SWP25280008SA SWP25280009SA SWP25280013SA SWP25280014SA SWP25280015SA SWP25280016SA SWP25280017SA SWP25160001SA SWP25160002SA SWP25160003SA SWP25160004SA SWP25160005SA SWP25160006SA SWP25160007SA SWP25160008SA SWP25160009SA SWP25160010SA SWP25160011SA SWP25160012SA SWP25160013SA SWP25160014SA SWP25160015SA SWP25160016SA SWP25160017SA SWP25160019SA SWP25160020SA SWP25160021SA SWP25160022SA SWP25160023SA SWP25160024SA SWP25220049SA SWP25310005SA SWP25040956SA SWP25260102SA SWP25260118SA SWP25290055SA SWP25151080SA SWP25151081SA SWP25270071SA SWP25220065SA SWP25151102SA SWP25151103SA SWP25151104SA SWP25151105SA SWP25151106SA SWP25151107SA SWP25210036SA SWP25210037SA SWP25210038SA SWP25210039SA SWP25210040SA SWP25210041SA SWP25210042SA SWP25210043SA SWP25151088SA SWP25151089SA SWP25151090SA SWP25151091SA SWP25151092SA SWP25151093SA SWP25151094SA SWP25151095SA SWP25151096SA SWP25151097SA SWP25151098SA SWP25151099SA SWP25151100SA SWP25151101SA SWP25110529SA SWP25110530SA SWP25110531SA SWP25120632SA SWP25300062SA SWP25300063SA SWP25130669SA SWP25130670SA SWP25170057SA SWP25240001SA SWP25240002SA SWP25130682SA SWP25130683SA SWP25130684SA SWP25130685SA SWP25130686SA SWP25130687SA SWP25130688SA SWP25130689SA SWP25130690SA SWP25130691SA SWP25130692SA SWP25130693SA SWP25130694SA SWP25130695SA SWP25040965SA SWP25040966SA SWP25040967SA SWP25040968SA SWP25040969SA SWP25040970SA SWP25040971SA SWP25040972SA SWP25040973SA SWP25040974SA SWP25040975SA SWP25040976SA SWP25040977SA SWP25040978SA SWP25040979SA SWP25040980SA SWP25040981SA SWP25040982SA SWP25040983SA SWP25040984SA SWP25040985SA SWP25040986SA SWP25040987SA SWP25040988SA SWP25040989SA SWP25040990SA SWP25040991SA SWP25040992SA SWP25040993SA SWP25040994SA SWP25040995SA SWP25040996SA SWP25040997SA SWP25040998SA SWP25040999SA SWP25041000SA SWP25041001SA SWP25041002SA SWP25041003SA SWP25041004SA SWP25041005SA SWP25041006SA SWP25041007SA SWP25041008SA SWP25041009SA SWP25041010SA SWP25041011SA SWP25041012SA SWP25041013SA SWP25041014SA SWP25041015SA SWP25041016SA SWP25041017SA SWP25041018SA SWP25041019SA SWP25041020SA SWP25041021SA SWP25041022SA SWP25041023SA SWP25041024SA SWP25041025SA SWP25041026SA SWP25041027SA SWP25041028SA SWP25041029SA SWP25041030SA SWP25041031SA SWP25041032SA SWP25041033SA SWP25041034SA SWP25041035SA SWP25041036SA SWP25041037SA SWP25041038SA SWP25041039SA SWP25041040SA SWP25041041SA SWP25041042SA SWP25041043SA SWP25041044SA SWP25041045SA SWP25041046SA SWP25041047SA SWP25041048SA SWP25041049SA SWP25041050SA SWP25041051SA SWP25041052SA SWP25041053SA SWP25041054SA SWP25041055SA SWP25041056SA SWP25041057SA SWP25041058SA SWP25041059SA SWP25041060SA SWP25041061SA SWP25041062SA SWP25041063SA SWP25041064SA SWP25041065SA SWP25041066SA SWP25041067SA SWP25041068SA SWP25041069SA SWP25041070SA SWP25041071SA SWP25041072SA SWP25041073SA SWP25051074SA SWP25051075SA SWP25051076SA SWP25051077SA SWP25051078SA SWP25051079SA SWP25051080SA SWP25051081SA SWP25051082SA SWP25051083SA SWP25051084SA SWP25051085SA SWP25051086SA SWP25051087SA SWP25051088SA SWP25051089SA SWP25051090SA SWP25051091SA SWP25051092SA SWP25051093SA SWP25051094SA SWP25051095SA SWP25051096SA SWP25051097SA SWP25051098SA SWP25051099SA SWP25051100SA SWP25051101SA SWP25051102SA SWP25051103SA SWP25051104SA SWP25051105SA SWP25051106SA SWP25051107SA SWP25051108SA SWP25051109SA SWP25051110SA SWP25051111SA SWP25051112SA SWP25051113SA SWP25051114SA SWP25051115SA SWP25051116SA SWP25051117SA SWP25051118SA SWP25051119SA SWP25051120SA SWP25051121SA SWP25051122SA SWP25051123SA SWP25051124SA SWP25051125SA SWP25051126SA SWP25051127SA SWP25051128SA SWP25051129SA SWP25051130SA SWP25051131SA SWP25051132SA SWP25051133SA SWP25051134SA SWP25051135SA SWP25051136SA SWP25051137SA SWP25051138SA SWP25051139SA SWP25051140SA SWP25051141SA SWP25051142SA SWP25051143SA SWP25051144SA SWP25051145SA SWP25051146SA SWP25051147SA SWP25051148SA SWP25051149SA SWP25051150SA SWP25051151SA SWP25051152SA SWP25051153SA SWP25051154SA SWP25051155SA SWP25051156SA SWP25051158SA SWP25051159SA SWP25051160SA SWP25051161SA SWP25051162SA SWP25051182SA SWP25051183SA SWP25051188SA SWP25051189SA SWP25051190SA SWP25051206SA SWP25051208SA SWP25051209SA SWP25051210SA SWP25051219SA SWP25051220SA SWP25080006SA SWP25080007SA SWP25080008SA SWP25080009SA SWP25080010SA SWP25080011SA SWP25080012SA SWP25080015SA SWP25080016SA SWP25080017SA SWP25080018SA SWP25080019SA SWP25080020SA SWP25080021SA SWP25080022SA SWP25080023SA SWP25080033SA SWP25080034SA SWP25080035SA SWP25080049SA SWP25080056SA SWP25080057SA SWP25080059SA SWP25080060SA SWP25080061SA SWP25080062SA SWP25080063SA SWP25080065SA SWP25080105SA SWP25080106SA SWP25080107SA SWP25080108SA SWP25080109SA SWP25080110SA SWP25080111SA SWP25080112SA SWP25080113SA SWP25080114SA SWP25080115SA SWP25080116SA SWP25080117SA SWP25080118SA SWP25080119SA SWP25080120SA SWP25080121SA SWP25080122SA SWP25080123SA SWP25080124SA SWP25080125SA SWP25080126SA SWP25080127SA SWP25080128SA SWP25080129SA SWP25080130SA SWP25080131SA SWP25080132SA SWP25080133SA SWP25080134SA SWP25080135SA SWP25080136SA SWP25080137SA SWP25080138SA SWP25080139SA SWP25080140SA SWP25080141SA SWP25080142SA SWP25080143SA SWP25080144SA SWP25080145SA SWP25080146SA SWP25080147SA SWP25080148SA SWP25080149SA SWP25080150SA SWP25080152SA SWP25080153SA SWP25080154SA SWP25080155SA SWP25080156SA SWP25080157SA SWP25080158SA SWP25080159SA SWP25080160SA SWP25080161SA SWP25080162SA SWP25080163SA SWP25080164SA SWP25080165SA SWP25080166SA SWP25080167SA SWP25080168SA SWP25080169SA SWP25110381SA SWP25110382SA SWP25110383SA SWP25110384SA SWP25110385SA SWP25110386SA SWP25110387SA SWP25110388SA SWP25110401SA SWP25110402SA SWP25110403SA SWP25110404SA SWP25110405SA SWP25110406SA SWP25110407SA SWP25110408SA SWP25110409SA SWP25110410SA SWP25110411SA SWP25110413SA SWP25110414SA SWP25110415SA SWP25110416SA SWP25110417SA SWP25110418SA SWP25110419SA SWP25110420SA SWP25110421SA SWP25110422SA SWP25110423SA SWP25110424SA SWP25110425SA SWP25110426SA SWP25110427SA SWP25110428SA SWP25110429SA SWP25110430SA SWP25110431SA SWP25110432SA SWP25110433SA SWP25110434SA SWP25110435SA SWP25110436SA SWP25110437SA SWP25110438SA SWP25110439SA SWP25110440SA SWP25110441SA SWP25110442SA SWP25110443SA SWP25110444SA SWP25110445SA SWP25110446SA SWP25110447SA SWP25110448SA SWP25110450SA SWP25110451SA SWP25110452SA SWP25110453SA SWP25110454SA SWP25110455SA SWP25110456SA SWP25110457SA SWP25110458SA SWP25110459SA SWP25110460SA SWP25110461SA SWP25110462SA SWP25110463SA SWP25110464SA SWP25110465SA SWP25110466SA SWP25110493SA SWP25110494SA SWP25110495SA SWP25110496SA SWP25110497SA SWP25110498SA SWP25110499SA SWP25110500SA SWP25110501SA SWP25110502SA SWP25110504SA SWP25110505SA SWP25110506SA SWP25110507SA SWP25110508SA SWP25110509SA SWP25110510SA SWP25110511SA SWP25110512SA SWP25110513SA SWP25110514SA SWP25110515SA SWP25110516SA SWP25110517SA SWP25110518SA SWP25130651SA SWP25130652SA SWP25130653SA SWP25130654SA SWP25130655SA SWP25130656SA SWP25130657SA SWP25130658SA SWP25130659SA SWP25130660SA SWP25130661SA SWP25130662SA SWP25130663SA SWP25130664SA SWP25130665SA SWP25130666SA SWP25130667SA SWP25130668SA SWP25160029SA SWP25160030SA SWP25080014SA SWP25080024SA SWP25080025SA SWP25080026SA SWP25080027SA SWP25080028SA SWP25080029SA SWP25080030SA SWP25080031SA SWP25080032SA SWP25151051SA SWP25151052SA SWP25151053SA SWP25170040SA SWP25170041SA SWP25190001SA SWP25190002SA SWP25190003SA SWP25190004SA SWP25190005SA SWP25190006SA SWP25190007SA SWP25190008SA SWP25190009SA SWP25190010SA SWP25190011SA SWP25190012SA SWP25190013SA SWP25190015SA SWP25190016SA SWP25190017SA SWP25190018SA SWP25190019SA SWP25190021SA SWP25190027SA SWP25190028SA SWP25190029SA SWP25190030SA SWP25190031SA SWP25190032SA SWP25190033SA SWP25190034SA SWP25190035SA SWP25190036SA SWP25190037SA SWP25190039SA SWP25190040SA SWP25190041SA SWP25190043SA SWP25190045SA SWP25190047SA SWP25190048SA SWP25190049SA SWP25190050SA SWP25190052SA SWP25190053SA SWP25190054SA SWP25190055SA SWP25190056SA SWP25190057SA SWP25190058SA SWP25190059SA SWP25190060SA SWP25210070SA SWP25280041SA SWP25280042SA SWP25190102SA SWP25190103SA SWP25220005SA SWP25220007SA SWP25260159SA SWP25280031SA SWP25120631SA SWP25151039SA SWP25151040SA SWP25151041SA SWP25151042SA SWP25151043SA SWP25151044SA SWP25151045SA SWP25151046SA SWP25270086SA SWP25270087SA SWP25270088SA SWP25141038SA SWP25051283SA SWP25250025SA SWP25250026SA SWP25250027SA SWP25250028SA SWP25250029SA SWP25230028SA SWP25300019SA SWP25300020SA SWP25300021SA SWP25300022SA SWP25300023SA SWP25300024SA SWP25170038SA SWP25170039SA SWP25250053SA SWP25240023SA SWP25240024SA SWP25240025SA SWP25240026SA SWP25240027SA SWP25240028SA SWP25240029SA SWP25240030SA SWP25240031SA SWP25240032SA SWP25240033SA SWP25240034SA SWP25240035SA SWP25240036SA SWP25130845SA SWP25130846SA SWP25130854SA SWP25130855SA SWP25141019SA SWP25141020SA SWP25141021SA SWP25141022SA SWP25141023SA SWP25141024SA SWP25141025SA SWP25141026SA SWP25141027SA SWP25141028SA SWP25141029SA SWP25141030SA SWP25210005SA SWP25210006SA SWP25210007SA SWP25210008SA SWP25210009SA SWP25210010SA SWP25210011SA SWP25210012SA SWP25210013SA SWP25210014SA SWP25210015SA SWP25210016SA SWP25210017SA SWP25210018SA SWP25210019SA SWP25210020SA SWP25210021SA SWP25210022SA SWP25210023SA SWP25210024SA SWP25210025SA SWP25210026SA SWP25210027SA SWP25210028SA SWP25210029SA SWP25210030SA SWP25210031SA SWP25210032SA SWP25210033SA SWP25210034SA SWP25210081SA SWP25290063SA SWP25230027SA SWP25250038SA SWP25250039SA SWP25250040SA SWP25170025SA SWP25170026SA SWP25280035SA SWP25280036SA SWP25300066SA SWP25200024SA SWP25200028SA SWP25151108SA SWP25151109SA SWP25170001SA SWP25170002SA SWP25170003SA SWP25170004SA SWP25170005SA SWP25170006SA SWP25170007SA SWP25170008SA SWP25170009SA SWP25170010SA SWP25170011SA SWP25170012SA SWP25170013SA SWP25220071SA SWP25130840SA SWP25130841SA SWP25130842SA SWP25090142SA SWP25090143SA SWP25090144SA SWP25090145SA SWP25090146SA SWP25090147SA SWP25090148SA SWP25090149SA SWP25090150SA SWP25090151SA SWP25090152SA SWP25090153SA SWP25090154SA SWP25090155SA SWP25090156SA SWP25090157SA SWP25090158SA SWP25090159SA SWP25090160SA SWP25090161SA SWP25090162SA SWP25090163SA SWP25090164SA SWP25090165SA SWP25090166SA SWP25090167SA SWP25090168SA SWP25090169SA SWP25120636SA SWP25151059SA SWP25151060SA SWP25151061SA SWP25151062SA SWP25240012SA SWP25040960SA SWP25040961SA SWP25061397SA SWP25200036SA SWP25200037SA SWP25140935SA SWP25140936SA SWP25140937SA SWP25250057SA SWP25250058SA SWP25061395SA SWP25061396SA SWP25080103SA SWP25170047SA SWP25230015SA SWP25230016SA SWP25230017SA SWP25100012SA SWP25130768SA SWP25130847SA SWP25260119SA SWP25220051SA SWP25220052SA SWP25220053SA SWP25220054SA SWP25220055SA SWP25220056SA SWP25220057SA SWP25220058SA SWP25220059SA SWP25220060SA SWP25220061SA SWP25220062SA SWP25170055SA SWP25240009SA SWP25240010SA SWP25240011SA SWP25300032SA SWP25300033SA SWP25300034SA SWP25300035SA SWP25151066SA SWP25151068SA SWP25151072SA SWP25190104SA SWP25250051SA SWP25250054SA SWP25250055SA SWP25250056SA SWP25190107SA SWP25090171SA SWP25130743SA SWP25141037SA SWP25260097SA SWP25280030SA SWP25280033SA SWP25280034SA SWP25310001SA SWP25170050SA SWP25130671SA SWP25130672SA SWP25130673SA SWP25130674SA SWP25130675SA SWP25130676SA SWP25250049SA SWP25260162SA SWP25170031SA SWP25210069SA SWP25250030SA SWP25250031SA SWP25300054SA SWP25300055SA SWP25300056SA SWP25300057SA SWP25300058SA SWP25300059SA SWP25300060SA SWP25300061SA SWP25270084SA SWP25270085SA SWP25051290SA SWP25051291SA SWP25170042SA SWP25170043SA SWP25230001SA SWP25230002SA SWP25230003SA SWP25151069SA SWP25210080SA SWP25220021SA SWP25220022SA SWP25250017SA SWP25250018SA SWP25250019SA SWP25250020SA SWP25250023SA SWP25250024SA SWP25120629SA SWP25120642SA SWP25270079SA SWP25270080SA SWP25200041SA SWP25210001SA SWP25210002SA SWP25240016SA SWP25250041SA SWP25270070SA SWP25110467SA SWP25110468SA SWP25110469SA SWP25110470SA SWP25110471SA SWP25110472SA SWP25110473SA SWP25110474SA SWP25110475SA SWP25110476SA SWP25110477SA SWP25130770SA SWP25130771SA SWP25130772SA SWP25130773SA SWP25130774SA SWP25130775SA SWP25130776SA SWP25130777SA SWP25130778SA 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SWP25090168WA SWP25090169WA SWP25090170WA SWP25090171WA SWP25090172WA SWP25090173WA SWP25090174WA SWP25090175WA SWP25090176WA SWP25160072WA SWP25160073WA SWP25210024WA SWP25070109WA SWP25070110WA SWP25070111WA SWP25070112WA SWP25170053WA SWP25170054WA SWP25290060WA SWP25160082WA SWP25160062WA SWP25160063WA SWP25160064WA SWP25290061WA SWP25160086WA SWP25300033WA (Updated 3/12/26 - additional serial nos. SWP24140086WA SWP24140087WA)
FEI Number 3002806783
Recalling Firm/
Manufacturer		 GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki Finland
For Additional Information ContactGE HealthCare Service
800-4371171 Ext. 2436
Manufacturer 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.
FDA Determined
Cause 2		Component change control
ActionOn 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.
Quantity in Commerce5990
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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