Mindray DS USA, Inc.: BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Mindray DS USA, Inc.
- Product
- BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
- Reason / hazard
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- Worldwide - Nationwide and the country of Canada.
- Recall initiated
- 2026-08-31
- 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
- Product quantity
- 29,737 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mahwah
- State
- NJ
- Country
- United States
- Event id
- 99828
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