PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 19, 2025 Initiated: September 26, 2025 #Z-0456-2026

Product Description

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.

Details

Recalling Firm
GE Healthcare Finland Oy
Units Affected
5990
Distribution
Worldwide - US Nationwide distribution.
Location
Helsinki

Frequently Asked Questions

What product was recalled?
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms. Recalled by GE Healthcare Finland Oy. Units affected: 5990.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0456-2026.