FDA Device recall Z-0456-2026
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms by Ge Healthcare Finland Oy, citing 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 situa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0456-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-26 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare Finland Oy |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA S…UDI-DI 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA SWP25130724SA SWP25130725SA SWP25130726SA SWP25130727SA SWP25130728SA SWP25130729SA SWP25130730SA SWP25130731SA SWP25130732SA SWP25130733SA SWP25130734SA SWP25130735SA SWP25130736SA SWP25130737SA SWP25130738SA SWP25130739SA SWP25130740SA SWP25130741SA SWP25230019SA SWP25230020SA SWP25230021SA SWP25230022SA SWP25230026SA SWP25210083SA SWP25210084SA SWP25130751SA SWP25130752SA SWP25130753SA SWP25170019SA SWP25170020SA SWP25170021SA SWP25170022SA SWP25170023SA SWP25170024SA SWP25200033SA SWP25200034SA SWP25200035SA SWP25160027SA SWP25180121SA SWP25180122SA SWP25180123SA SWP25230034SA SWP25230035SA SWP25230036SA SWP25250032SA SWP25250033SA SWP25290061SA SWP25260114SA SWP25260115SA SWP25260116SA SWP25260117SA SWP25250046SA SWP25250047SA SWP25250048SA SWP25250050SA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0456-2026%22
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