- Recalling firm
- Mindray DS USA, Inc.
- Reason for recall
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Affected products (lot / model / serial)
- 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
- Units affected
- 39,891 units
- Distribution pattern
- Worldwide - Nationwide and the country of Canada.
- Firm location
- Mahwah, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0114-2027
- Recall initiated
- August 31, 2026
- FDA classification date
- October 7, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99828
- Last updated on HTM Vibe
- October 21, 2026
