FDA recall Z-0454-2026

GE Healthcare Finland Oy · Class II · device

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

Status: Ongoing
Initiation date: 2025-09-26
Report date: 2025-11-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Helsinki, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2026