Mindray Ds Usa, Inc.: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary Mindray DS USA is recalling certain ePM Series patient monitors because their operator manuals contain unclear or incomplete descriptions of how the physiological alarm functions work. This recall affects ePM 10M, ePM 12M, ePM 12MA, ePM 15M, and ePM 10A monitors distributed nationwide, in Canada, and worldwide. The FDA classified this as a Class II recall.
- Recalling firm
- Mindray DS USA, Inc.
- Product
- ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ef42a30b-3a34-4052-b6a6-633d9b894129