ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Reason | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Risk class | Class III (Class III · low) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Aug 31, 2026 |
| Region | NJ, United States |
| Distribution | Worldwide - Nationwide and the country of Canada. |
| Quantity | 32,184 units |
| Code/Lot | 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 u… |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0109-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0109-2027)
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