Mindray Ds Usa, Inc.: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
- Recalling firm
- Mindray DS USA, Inc.
- Product
- Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
- 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/417b54ab-7731-4208-a2bc-1fc16bf60059