Mindray DS USA, Inc. — ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Official product recall notices and clearly labeled enforcement reference records.
Reference record — not a live warning · enforcement-reference · official-source
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Posted by source
- Source last updated
- Current version retrieved
- Provider
- FDA — device enforcement reference
- Location
- Mahwah, NJ, US
- hazard
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- notice
- Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
- product
- ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
- distribution
- Worldwide - Nationwide and the country of Canada.
- event number
- 99828
- manufacturer
- Mindray DS USA, Inc.
- recall number
- Z-0109-2027
- source status
- Open, Classified
- freshness minutes
- 180
Source use policy · openFDA reference data; not a real-time public alert service
Update history (1 recent revisions)
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