Mindray Ds Usa, Inc.: System, Network And Communication, Physiological Monitors
Recall Summary Mindray DS USA, Inc. is recalling operator's manuals for BeneVision Series Telemetry Monitors (models TM70/TM80) because the manuals contain unclear or incomplete descriptions of certain physiological alarm functions. The recall affects manuals distributed nationwide, in Canada, and internationally. This is a Class II recall, meaning the issue is unlikely to cause serious harm but requires correction.
- Recalling firm
- Mindray DS USA, Inc.
- Product
- BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
- 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/d5b302ff-1f36-459a-bbe6-af634bc11727