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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

GE Healthcare Finland Oy: 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.

Agency Publication Date: November 7, 2025
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Summary

GE Healthcare Finland Oy has recalled approximately 7,408 B105P, B125P, B105M, B125M, and B155M Patient Monitors due to a defect in the backup batteries. These specific physiological monitors, used for tracking patient vitals and arrhythmia detection, may contain batteries that fail to hold a charge or provide backup power when needed. This flaw can lead to a complete loss of patient monitoring, potentially preventing medical staff from seeing critical changes in a patient's condition.

Risk

The affected batteries can lose the capability to provide backup power during a power failure or transport; if this occurs, the monitor will shut down unexpectedly, causing a loss of patient monitoring and potentially delaying life-saving treatment.

What You Should Do

  1. Identify if your facility uses GE Healthcare B105P, B125P, B105M, B125M, or B155M monitors by checking the model and serial numbers on the device label.
  2. Verify your specific device against the extensive list of affected serial numbers, which include models such as 6160000-002, 6160000-003, 6160000-004, 6160000-005, and 6160000-101.
  3. Ensure affected monitors remain connected to a reliable AC (wall) power source at all times to prevent unexpected shutdown due to battery failure.
  4. Follow any specific field safety notices or technical instructions provided directly by GE Healthcare regarding battery testing or replacement.
  5. Contact GE Healthcare Finland Oy or your local GE service representative for technical support and to arrange for any necessary battery replacements or hardware updates.
  6. For additional information or questions regarding this device recall, contact the FDA at 1-888-INFO-FDA (1-888-463-6332).

Affected Products

Product: GE Healthcare B105P Patient Monitor
Model / REF:
6160001-061
Product: GE Healthcare B125P Patient Monitor
Model / REF:
6160001-062
Lot Numbers:
SR722080015WA
SR722080014WA
Product: GE Healthcare B105M Patient Monitor
Model / REF:
6160000-002
6160000-113 (B105M-A)
6160002-033 (B105M-C)
UPC Codes:
00840682147224
Lot Numbers:
SR525270031WA
SR525270060WA
Product: GE Healthcare B125M Patient Monitor
Model / REF:
6160000-003
6160000-004
UPC Codes:
00840682146708
00840682146715
Lot Numbers:
SR625210256SA
SR625200211SA
SR725210312SA
Product: GE Healthcare B155M Patient Monitor
Model / REF:
6160000-005
6160000-115 (B155M-A)
UPC Codes:
00840682146791
Lot Numbers:
SR825130013SA
SR825200001SA
Product: GE Healthcare Patient Monitor (Physiological)
Model / REF:
6160000-101
6160000-102
6160000-103
6160000-104
6160000-105
6160001-063
6160001-064
6160001-065
UPC Codes:
00195278488473
Lot Numbers:
SV225080093WA
SV225210123WA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97786
Status: Active
Manufacturer: GE Healthcare Finland Oy
Manufactured In: Finland
Units Affected: 5 products (3271; 5935; 7408; 5990; 2857)
Agency Last Updated: March 19, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.