[pending] B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6
Pending LLM rewrite. Source: FDA_DEVICE Z-0455-2026.
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
- B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3
- Manufacturer
- GE Healthcare Finland Oy
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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