Class II U.S. Food and Drug Administration

GE Healthcare Finland Oy Carescape B450 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-0453-2026
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
3271
Distribution
Nationwide
Made in
Finland
Lot / code info
UDI-DI 00840682146135 Serial numbers 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 SNT25069023SA SNT25259594SA SNT25259577SA SNT25259590SA SNT25069508SA SNT25069564SA SNT25219502SA SNT25219501SA SNT25219504SA SNT25219503SA SNT25079536SA SNT25079537SA SNT25079558SA SNT25079532SA SNT25079569SA SNT25079539SA SNT25079526SA SNT25079571SA SNT25079575SA SNT25079576SA SNT25079572SA SNT25079574SA SNT25079533SA SNT25079524SA SNT25079573SA SNT24429994SA SNT25149512SA SNT25149514SA SNT25109580SA SNT25109578SA SNT25109576SA SNT25109579SA SNT25109577SA SNT25109574SA SNT25109575SA SNT25109581SA SNT25109573SA SNT25179587SA SNT25179583SA SNT25179577SA SNT25179573SA SNT25179574SA SNT25019477SA SNT24529475SA SNT24529472SA SNT25019494SA SNT25099727SA SNT25099728SA SNT25099729SA SNT25099730SA SNT25099732SA SNT25099733SA SNT25099736SA SNT25099735SA SNT25099737SA SNT25099738SA SNT25109521SA SNT25109514SA SNT25199525SA SNT25199527SA SNT25199528SA SNT25199519SA SNT25199521SA SNT25199526SA SNT25199524SA SNT25199540SA SNT25089012SA SNT25259570SA SNT25269581SA SNT25269583SA SNT25269582SA SNT25269589SA SNT25269591SA SNT25269588SA SNT25269594SA SNT25269599SA SNT25269596SA SNT25269593SA SNT25159685SA SNT24529627SA SNT25019502SA SNT25149516SA SNT25149520SA SNT25149519SA SNT25149521SA SNT25149525SA SNT25249599SA SNT25249600SA SNT25249602SA SNT25249023SA SNT25249017SA SNT25249008SA SNT25249022SA SNT25249028SA SNT25249018SA SNT25249016SA SNT25249020SA SNT25249021SA SNT25249009SA SNT25249019SA SNT25249014SA SNT25249029SA SNT25249026SA SNT25169503SA SNT25169504SA SNT25149508SA SNT25149507SA SNT25149503SA SNT25149502SA SNT25289014SA SNT25289016SA SNT25289018SA SNT25289017SA SNT25289019SA SNT25289020SA SNT25289021SA SNT25289022SA SNT25289026SA SNT25289024SA SNT25289025SA SNT25289023SA SNT25289027SA SNT25289028SA SNT25289030SA SNT25289031SA SNT25289032SA SNT25289029SA SNT25289035SA SNT25289034SA SNT25289033SA SNT25289038SA SNT25289037SA SNT25289036SA SNT25289013SA SNT25289039SA SNT25289042SA SNT25289040SA SNT25289015SA SNT25289052SA SNT25289049SA SNT25289046SA SNT25289053SA SNT25289054SA SNT25289050SA SNT25289045SA SNT25289048SA SNT25289051SA SNT25289043SA SNT25289044SA SNT25289041SA SNT25289047SA SNT24529471SA SNT25019479SA SNT25119501SA SNT25159687SA SNT25199564SA SNT25199600SA SNT25199568SA SNT25249560SA SNT25249557SA SNT25249559SA SNT25249571SA SNT25249567SA SNT25249569SA SNT25249533SA SNT25249572SA SNT25249573SA SNT25249575SA SNT25249568SA SNT25249556SA SNT25249565SA SNT25249570SA SNT25249574SA SNT25249506SA SNT25249564SA SNT25249576SA SNT25249555SA SNT25249554SA SNT25249581SA SNT25249596SA SNT25249592SA SNT25249597SA SNT25249595SA SNT25249601SA SNT25249591SA SNT24206039SA SNT24206077SA SNT25069024SA SNT25099001SA SNT25099005SA SNT25099003SA SNT25099004SA SNT25099006SA SNT25289533SA SNT25289532SA SNT25139501SA SNT25309501SA SNT25309504SA SNT25119530SA SNT25119003SA SNT25119004SA SNT25119001SA SNT25119002SA SNT25269502SA SNT25269504SA SNT25269513SA SNT25269512SA SNT25269511SA SNT25269510SA SNT25269516SA SNT25269518SA SNT25249589SA SNT25249582SA SNT25249594SA SNT25249587SA SNT25249593SA SNT25249598SA SNT25129019SA SNT25129018SA SNT25129017SA SNT25129016SA SNT25129626SA SNT25259004SA …
UPC codes
00840682146135

Products covered by this recall

Carescape 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 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001

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.

  • 00840682146135

Serial number

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

  • SNT25079613SA SNT25079608SA SNT25079622SA

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. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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 00840682146135. 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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