BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Reason | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Risk class | Class III (Class III · low) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Aug 31, 2026 |
| Region | NJ, United States |
| Distribution | Worldwide - Nationwide and the country of Canada. |
| Quantity | 29,737 units |
| Code/Lot | 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. BeneV… |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0111-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0111-2027)
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This page summarizes U.S. FDA data for general information and is not medical advice. Confirm details via official FDA announcements and the manufacturer.