Official recall notice
Passport Series Patient Monitor Recall (Oct 2026)
Product: Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
- Recall date
- 2026-10-14
- Brand
- Mindray DS USA, Inc.
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
Hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Product description
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Affected products
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