# FDA recall Z-0455-2026

> **GE Healthcare Finland Oy** · Class II · device recall initiated 2025-09-26.

## Product

B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101  6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065  Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms  3/19/26 updated to add B105P Patient Monitor 6160001-061  B125P Patient Monitor 6160001-062  B105M-C Patient Monitor 6160002-033  B105M-A Patient Monitor 6160000-113  B155M-A Patient Monitor 6160000-115  B125P-B Patient Monitor 6160002-022  B105M-B Patient Monitor 6160002-023  B125M-B Patient Monitor 6160002-024  B105M-OR Patient Monitor 6160000-143  B105M-OR Patient Monitor 6160000-144  B155M-OR Patient Monitor 6160000-145

## 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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0455-2026
- **Recalling firm:** GE Healthcare Finland Oy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-26
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Helsinki, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0455-2026

## Citation

> AI Analytics. FDA recall Z-0455-2026. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0455-2026. Source: US FDA. Licensed CC0.

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