LowFDAOngoing
Unlikely to cause harm, but it breaks the rules.
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Check the device or its packaging for
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
- Why
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Distributed
- Worldwide - Nationwide and the country of Canada.
- Company
- Mindray DS USA, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0114-2027 · retrieved 7 October 2026
Read the official notice