Class IIIDeviceOngoing

Mindray DS USA, Inc.

BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80

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-0111-2027
Event ID: 99828
Recall initiated: Aug 31, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 29,737 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 BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00