GE Healthcare Finland Oy: Device Recall
Recall #Z-0456-2026 · 09/26/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0456-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- GE Healthcare Finland Oy
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Helsinki, Finland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5990
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.
Product Description
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Distribution Pattern
Worldwide - US Nationwide distribution.
Other Recalls by GE Healthcare Finland Oy
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.