Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama... recall (Mindray DS USA, Inc.)
Medical deviceClass IIIOngoing
Summary: Mindray DS USA, Inc. is recalling Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).. Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.
What is being recalled
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Why
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Worldwide - Nationwide and the country of Canada.
How to tell if yours is affected
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 to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0112-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 31, 2026 |
| Reported | October 14, 2026 |
| Company | Mindray DS USA, Inc. |
| Company location | Mahwah, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11,831 units |
More recalls from Mindray DS USA, Inc. · all medical device recalls · recalls from August 2026