Class 2 Device Recall CARESCAPE ONE

• Date Initiated by Firm: September 26, 2025
• Date Posted: November 07, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0454-2026
• Recall Event ID: 97786
• 510(K)Number: K213234
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: 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
• Code Information: UDI-DI 00195278288639 Serial numbers 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 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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 SV925270149SA SV925270165SA SV925270138SA SV925270144SA SV925270163SA SV925260116SA SV925270155SA SV925270233SA SV925270106SA SV925270157SA SV925270166SA SV925270136SA SV925270162SA SV925080108SA SV925080109SA SV925070426SA SV925080101SA SV925080106SA SV925080097SA SV925080105SA SV925100150SA SV925100043SA SV925100073SA SV925100116SA SV925100146SA SV925060286SA SV925070181SA SV925220338SA SV925180066SA SV925180145SA SV925110061SA SV925110058SA SV925110055SA SV925110052SA SV925110054SA SV925120052SA SV925090096SA SV925180200SA SV925180130SA SV925060261SA SV925060239SA SV925060253SA SV925060242SA SV925230418SA SV925230412SA SV925230410SA SV925230455SA SV925230442SA SV925230414SA SV925230408SA SV925230417SA SV925230407SA SV925230421SA SV925230416SA SV925230401SA SV925230409SA SV925230422SA SV925230444SA SV925230411SA SV925230404SA SV925230452SA SV925230437SA SV925230406SA SV925230419SA SV925230394SA SV925230439SA SV925230528SA SV925230549SA SV925230381SA SV925230457SA SV925230447SA SV925230451SA SV925230472SA SV925230440SA SV925230445SA SV925230400SA SV925230449SA SV925230443SA SV925230453SA SV925220346SA SV925230392SA SV925230454SA SV925230375SA SV925240893SA SV925240873SA SV925240884SA SV925240878SA SV925240881SA SV925240858SA SV925240872SA SV925240885SA SV925240896SA SV925240879SA SV925250098SA SV925240880SA SV925240888SA SV925240900SA SV925250097SA SV925250089SA SV925250113SA SV925250119SA SV925250096SA SV925240882SA SV925240740SA SV925240883SA SV925240889SA SV925240894SA SV925240891SA SV925240871SA SV925240874SA SV925240869SA SV925240898SA SV925240886SA SV925250101SA SV925240812SA SV925250103SA SV925250100SA SV925250117SA SV925250014SA SV925250116SA SV925250120SA SV925250099SA SV925280114SA SV925260017SA SV925260018SA SNA24230142SA SV925260027SA SV925260015SA SV925260026SA SV925260022SA SV925260021SA SV925160104SA SV925150192SA SV925220329SA SV925220326SA SV925220313SA SV925220314SA SV925220312SA SV925220322SA SV925220321SA SV925220264SA SV925220265SA SV925220327SA SV925220266SA SV925220217SA SV925220261SA SV925220269SA SV925220260SA SV925220259SA SV925220256SA SV925220263SA SV925220305SA SV925220320SA SV925220331SA SV925220250SA SV925220270SA SV925220310SA SV925220271SA SV925220292SA SV925220315SA SV925220257SA SV925220328SA SV925220333SA SV925220316SA SV925220317SA SV925220319SA SV925220318SA SV925220268SA SV925220299SA SV925220332SA SV925250011SA SV925250008SA SV925250007SA SV925240904SA SV925250002SA SV925230476SA SV925240908SA SV925240892SA SV925240890SA SV925240895SA SV925250004SA SV925250005SA SV925240913SA SV925240910SA SV925240912SA SV925240909SA SV925250001SA SV925250003SA SV925240901SA SV925250006SA SV925250010SA SV925250009SA SV925260041SA SV925180034SA SV925170046SA SV925180032SA SV925180039SA SV925170039SA SV925170042SA SV925180033SA SV925180028SA SV925170050SA SV925180027SA SV925180051SA SV925180001SA SV925170047SA SV925170033SA SV925170038SA SV925180054SA SV925180003SA SV925180009SA SV925180026SA SV925180021SA SV925170017SA SV925180020SA SV925170011SA SV925180030SA SV925170007SA SV925260109SA SV925260106SA SV925260086SA SV925120016SA SV925260053SA SV925260108SA SV925090109SA SV925090112SA SV925060139SA SV925090082SA SV925090090SA SV925180016SA SV925180042SA SV925180049SA SV925180024SA SV925180036SA SV925180025SA SV925180041SA SV925180035SA SV925180043SA SV925180040SA SV925180045SA SV925180047SA SV925180048SA SV925180022SA SV925180038SA SV925180046SA SV925150134SA SV925180017SA SV925180037SA SV925180014SA SV925170014SA SV925180010SA SV925180011SA SV925180044SA SV925170008SA SV925170005SA SV925160129SA SV925220337SA SV925220276SA SV925220334SA SV925220335SA SV925250162SA SV925250147SA SV925250140SA SV925250155SA SV925250151SA SV925250090SA SV925250139SA SV925250138SA SV925250146SA SV925250157SA SV925250158SA SV925250149SA SV925250152SA SV925250145SA SV925250137SA SV925250124SA SV925250142SA SV925260039SA SV925260058SA SV925250144SA SV925250156SA SV925250154SA SV925250153SA SV925250150SA SV925250143SA SV925250161SA SV925250045SA SV925250160SA SV925250148SA SV925250141SA SV925250159SA SV925150100SA SV925150090SA SV925150099SA SV925150098SA SNA24400030SA SV925270051SA SV925270024SA SNA24420008SA SNA24410002SA SV925270019SA SV925260083SA SV925280015SA SV925300039SA SV925300037SA SV925290015SA SV925120062SA SV925100080SA SV925100096SA SV925100137SA SV925100138SA SV925150014SA SV925100142SA SV925100128SA SV925150013SA SV925100104SA SV925150027SA SV925150005SA SV925150016SA SV925140003SA SV925090136SA SV925150021SA SV925100135SA SV925150029SA SV925100018SA SV925100111SA SV925150015SA SV925150019SA SV925100098SA SV925140015SA SV925140013SA SV925150028SA SV925140009SA SV925100101SA SV925100205SA SV925100105SA SV925140007SA SV925150012SA SV925100122SA SV925150022SA SV925100071SA SV925100068SA SV925150026SA SV925150020SA SV925150011SA SV925150003SA SV925150018SA SV925100003SA SV925140010SA SV925140002SA SV925150017SA SV925140005SA SV925150025SA SV925150023SA SV925100133SA SV925060191SA SV925200049SA SV925210081SA SV925210080SA SV925210086SA SV925210083SA SV925210079SA SV925210091SA SV925200047SA SV925210078SA SV925210087SA SV925210076SA SV925180094SA SV925200053SA SV925200075SA SV925200039SA SV925210082SA SV925200069SA SV925210084SA SV925210077SA SV925060076SA SV925260102SA SV925260101SA SV925060136SA SV925050205SA SV925060051SA SV925060160SA SV925060230SA SV925060055SA SV925060070SA SV925060163SA SV925060162SA SV925260082SA SV925260081SA SV925260090SA SV925270115SA SV925110056SA SV925060100SA SV925060115SA SV925060116SA SV925060111SA SV925060102SA SV925060093SA SV925060105SA SV925060110SA SV925060107SA SV925060068SA SV925060106SA SV925060052SA SV925080313SA SV925080327SA SV925080310SA SV925080303SA SV925080259SA SV925080257SA SV925080317SA SV925080318SA SV925080321SA SV925080322SA SV925080290SA SV925080301SA SV925080285SA SV925080324SA SV925080309SA SV925080274SA 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SV925060275SA SV925060267SA SV925060250SA SV925060274SA SNA24162819SA SV925060244SA SV925200001SA SV925060252SA SV925060243SA SV925060254SA SNA24162773SA SV925060263SA SV925060238SA SV925200002SA SV925060280SA SV925060264SA SV925060290SA SV925060249SA SV925190025SA SV925180194SA SV925190016SA SV925190024SA SV925180197SA SV925190022SA SV925080083SA SV925080007SA SV925080085SA SV925080075SA SV925080077SA SV925080076SA SV925080017SA SV925080003SA SV925080023SA SV925080064SA SV925080018SA SV925080031SA SV925080073SA SV925080065SA SV925080087SA SV925080067SA SV925080082SA SV925100199SA SV925100202SA SV925220309SA SV925090075SA SV925090078SA SV925090076SA SV925090077SA SV925180137SA SV925180201SA SV925180138SA SV925180150SA SV925180157SA SV925180186SA SV925170025SA SV925180190SA SV925180189SA SV925180167SA SV925180153SA SV925180156SA SV925180154SA SV925180133SA SV925180109SA SV925180172SA SV925180168SA SV925180170SA SV925180162SA SV925190005SA SV925180174SA SV925180160SA SV925180155SA 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SV925050012SA SNA24360133SA SV925050092SA SNA24330061SA SNA24180028SA SV925050087SA SNA24510283SA SV925050089SA SV925050098SA SV925050097SA SV925050090SA SNA24400084SA SNA24300242SA SV925050081SA SV925050078SA SNA24400072SA SV925050080SA SNA24112157SA SNA24112185SA SV925050086SA SNA24400076SA SNA24180041SA SV925050079SA SNA24180049SA SNA24180047SA SV925060375SA SV925060421SA SV925060428SA SV925060425SA SV925060423SA SV925060397SA SV925060431SA SV925060233SA SV925060237SA SV925060407SA SV925060441SA SV925060417SA SV925060427SA SV925060424SA SV925060437SA SV925060439SA SV925060434SA SV925060443SA SV925060442SA SV925060448SA SV925060433SA SV925060429SA SV925080138SA SV925110045SA SV925160073SA SV925160090SA SV925190004SA SV925190001SA SV925190011SA SV925180147SA SV925190027SA SV925180185SA SV925190026SA SV925190031SA SV925260100SA SV925260099SA SV925070490SA SV925070465SA SV925080041SA SV925080155SA SV925180192SA SV925180191SA SV925180176SA SV925180184SA SV925160110SA SV925180171SA 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SV925270038SA SV925270089SA SV925270098SA SV925270102SA SV925270114SA SV925250201SA SNA24420006SA SNA24260145SA SV925260011SA SV925270096SA SV925270100SA SV925250200SA SV925250202SA SV925270083SA SV925260104SA SV925250203SA SV925250199SA SV925260096SA SV925270078SA SV925270079SA SV925270057SA SV925270032SA SV925270101SA SV925270090SA SV925080282SA SV925080299SA SV925080142SA SV925190038SA SV925200038SA SV925200037SA SV925200011SA SV925200041SA SV925050167SA SV925200056SA SV925170032SA SV925200036SA SV925200066SA SV925200068SA SV925190042SA SV925230450SA SV925250170SA SV925250188SA SV925250177SA SV925250185SA SV925250168SA SV925070435SA SV925070500SA SV925190023SA SV925190019SA SV925060231SA SV925060226SA SV925060289SA SV925060277SA SV925060292SA SV925060234SA SV925060165SA SV925060195SA SV925060268SA SV925060247SA SV925060251SA SV925060262SA SV925060260SA SV925060256SA SV925060232SA SV925060236SA SV925060266SA SV925060259SA SV925260025SA SV925260024SA SV925260023SA SV925260047SA 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• FEI Number: 3002806783
• Recalling Firm/ Manufacturer: GE Healthcare Finland Oy; Kuortaneenkatu 2; Helsinki Finland
• For Additional Information Contact: GE 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: Component change control
• Action: 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.
• Quantity in Commerce: 5935
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = MHX