FDA recall Z-0456-2026

GE Healthcare Finland Oy · Class II · device

Product

Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms

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-0456-2026