Mindray DS USA, Inc.: Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Mindray DS USA, Inc.
- Product
- Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
- Reason / hazard
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- Worldwide - Nationwide and the country of Canada.
- Recall initiated
- 2026-08-31
- 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
- Product quantity
- 39,891 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mahwah
- State
- NJ
- Country
- United States
- Event id
- 99828
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