⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Mindray DS USA, Inc.: Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).

Medical DevicesSource: FDA (device) · Date: 2026-10-14

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Mindray DS USA, Inc.
Product
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Reason / hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Classification
Class III
Status
Ongoing
Distribution / sold at
Worldwide - Nationwide and the country of Canada.
Recall initiated
2026-08-31
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
Product quantity
11,831 units
Voluntary mandated
Voluntary: Firm initiated
City
Mahwah
State
NJ
Country
United States
Event id
99828
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