Class IIIDeviceOngoing

Mindray DS USA, Inc.

T1 Patient Monitor. Operator's Manual: T1 Patient Monitor

Reason for recall

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

Details

Recall number: Z-0116-2027
Event ID: 99828
Recall initiated: Aug 31, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 4,946 units
Distribution: Worldwide - Nationwide and the country of Canada.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Mahwah, NJ, United States
Lot / code info: T1 Patient Monitor Operator's Manual: 1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00