- 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 ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00 2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00 3. ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00 4. ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00 5. ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00
- Units affected
- 32,184 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-0109-2027
- 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
