Device recall
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
- Recall number
- Z-0111-2027
- Event id
- 99828
- Status
- Ongoing
- FDA classification
- Class III
- Recalling firm
- Mindray DS USA, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 31, 2026
- Center classification date
- Oct 7, 2026
- Product code
- MSX
- Device type
- System, Network And Communication, Physiological Monitors
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Root cause
- Labeling design
- Quantity
- 29,737 units
- 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
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K242728
- Location
- Mahwah, NJ, United States