Official recall notice

FDA DeviceClass IIINotable

BeneVision Series Telemetry Monitor Recall (Oct 2026)

Product: BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80

Recall date
2026-10-14
FDA class
Class III

Why it was recalled

Hazard

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

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Product description

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Affected products

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

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