Medical device recalls Moderate risk

GE Healthcare Finland Oy recalls Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms

Recall date
September 26, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0456-2026
FDA classification
Class II
Brand / firm
GE Healthcare Finland Oy
Sold / distributed
Worldwide - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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