[pending] CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batte
Pending LLM rewrite. Source: FDA_DEVICE Z-0454-2026.
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
- CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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