Device recall
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
- Recall number
- Z-0114-2027
- Event id
- 99828
- Status
- Ongoing
- FDA classification
- Class III
- Recalling firm
- Mindray DS USA, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 31, 2026
- Center classification date
- Oct 7, 2026
- Product code
- MHX
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Root cause
- Labeling design
- Quantity
- 39,891 units
- 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
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Mahwah, NJ, United States