Class II U.S. Food and Drug Administration

GE Healthcare Finland Oy Carescape ONE recall: Potential loss of monitoring on affected monitors when powered by certain

Recall published 11 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0454-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Healthcare Finland Oy
Product type
Medical devices
Units affected
5935
Distribution
Nationwide
Made in
Finland
Lot / code info
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 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 …
UPC codes
00195278288639

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00195278288639

Serial number

On the rating plate, often next to the date of manufacture.

  • SV925270018SA SV925270014SA SV925270015SA

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

GE Healthcare Finland Oy — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: GE Healthcare Finland Oy — Kuortaneenkatu 2, Helsinki

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Healthcare Finland Oy medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00195278288639. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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