LowFDAOngoing
Unlikely to cause harm, but it breaks the rules.
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Check the device or its packaging for
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
- Why
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Distributed
- Worldwide - Nationwide and the country of Canada.
- Company
- Mindray DS USA, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0111-2027 · retrieved 7 October 2026
Read the official notice