# FDA recall Z-0454-2026

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

## Product

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

## 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-0454-2026
- **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-0454-2026

## Citation

> AI Analytics. FDA recall Z-0454-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0454-2026. Source: US FDA. Licensed CC0.

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