Mindray Ds Usa, Inc.: System, Network And Communication, Physiological Monitors
Recall Summary Mindray DS USA is recalling operator's manuals for its Panorama and Telemetry Monitoring System because the instructions contain unclear or incomplete descriptions of how certain physiological alarm functions work. The recall affects manuals distributed nationwide across the U.S., Canada, and other countries for models TMS-6016/Panorama Telepack-608/TMS60 (TD60).
- Recalling firm
- Mindray DS USA, Inc.
- Product
- Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
- 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/f329c3b0-78a9-41a9-8ea0-3dc2b83f4a18