Mindray DS USA, Inc. recalls Panorama and Telemetry Monitoring System. Operator's Manuals
See all recalls from Mindray DS USA, Inc. →Recalled Product
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
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 the Panorama and Telemetry Monitoring System Operator's Manuals: 1. Panorama Telepack-608 Telemetry Monitoring System Operator's Manual up to and including revision 1.0; Part No. 046-007526-00 2. TMS-6016 Operator's Manual up to and including revision 11.0; Part No. 046-005012-00
✅ 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.
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