[pending] Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection
Pending LLM rewrite. Source: FDA_DEVICE Z-0456-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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