Recall Z-0456-2026— GE Healthcare Finland Oy

Name: FDA recall Z-0456-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare Finland Oy, initiated 2025-09-26. It names one FDA 510(k) clearance: K233810. Product: Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms. Reason: 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..

Recalling firm: GE Healthcare Finland Oy
Classification: Class II
Status: Ongoing
Initiated: 2025-09-26
Firm location: Helsinki, Finland

510(k) clearances named in this recall

1 on FDA's record

K233810 — Portrait VSMGe Medical Systems Information Technologies, Inc.·cleared 2024-04-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.