Class IIIDeviceOngoing

Mindray DS USA, Inc.

Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).

Reason for recall

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Details

Recall number: Z-0112-2027
Event ID: 99828
Recall initiated: Aug 31, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 11,831 units
Distribution: Worldwide - Nationwide and the country of Canada.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Mahwah, NJ, United States
Lot / code info: Part Numbers of the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00 2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-00