Mindray DS USA, Inc. recalls BeneVision Series Telemetry Monitor. Operator's Manuals: TM7
See all recalls from Mindray DS USA, Inc. →Recalled Product
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Hazard / Issue
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Issued by
FDA
Distribution: Nationwide (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
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for BeneVision Series Telemetry Monitor. →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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