Reported Nov 19, 2025 · Ongoing

Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a…

GE Healthcare Finland Oy

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare Finland Oy · Kuortaneenkatu 2 · Helsinki · N/A

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
2095800-001Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313
2068491-002CARESCAPE MONITOR B450 (ATO MODEL)
2107633-001CARESCAPE MONITOR B450 B1
Lot codes and dates
  • UDI-DI 00840682146135 Serial numbers

    2,326 of 2,326 codes

    • SNT25079613SA
    • SNT25079608SA
    • SNT25079622SA
    • SNT25079618SA
    • SNT25079619SA
    • SNT25079614SA
    • SNT25079611SA
    • SNT25079621SA
    • SNT25079620SA
    • SNT25079603SA
    • SNT25079616SA
    • SNT25079612SA
    • SNT25079602SA
    • SNT25079615SA
    • SNT25079663SA
    • SNT25079664SA
    • SNT25079677SA
    • SNT25079662SA
    • SNT25079667SA
    • SNT25079678SA
    • SNT25079680SA
    • SNT25079666SA
    • SNT25079695SA
    • SNT25079694SA
    • SNT25079697SA
    • SNT25079688SA
    • SNT25079687SA
    • SNT25079685SA
    • SNT25079676SA
    • SNT25079674SA
    • SNT25079671SA
    • SNT25079691SA
    • SNT25079689SA
    • SNT25079679SA
    • SNT25079681SA
    • SNT25079684SA
    • SNT25079672SA
    • SNT25079668SA
    • SNT25079665SA
    • SNT25079675SA
    • SNT25079693SA
    • SNT25069004SA
    • SNT25069001SA
    • SNT25069002SA
    • SNT25069003SA
    • SNT25069013SA
    • SNT25069007SA
    • SNT25069015SA
    • SNT25069012SA
    • SNT25069014SA
    • SNT25069016SA
    • SNT25069017SA
    • SNT25069021SA
    • SNT25069019SA
    • SNT25069006SA
    • SNT25069020SA
    • SNT25069005SA
    • SNT25069008SA
    • SNT25069009SA
    • SNT25069018SA
Amount recalled
3271

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.