Class IIIDeviceOngoing

Mindray DS USA, Inc.

Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V

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-0114-2027
Event ID: 99828
Recall initiated: Aug 31, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 39,891 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: Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00 2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00 3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02