[pending] Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batterie
Pending LLM rewrite. Source: FDA_DEVICE Z-0453-2026.
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 B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE M
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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