Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Mindray DS USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- BeneVision Series Telemetry Monitor
- Operator's ManualsTM70/TM80
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 046-011232-00BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0 046-019362-00BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0 046-012662-00TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0 046-007056-00TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0 - Amount recalled
- 29,737 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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