FDA Device recall Z-0109-2027
ePM Series Patient Monitor
- FDA Device
- Class III
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class III recall of ePM Series Patient Monitor by Mindray Ds Usa, citing certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0109-2027 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-31 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
Product
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Reason
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Identifiers
| code_info | Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to a…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Mindray Ds Usa
- T1 Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - BeneVision Series Telemetry Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - BeneVision N1 and N-Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - cPM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - Passport Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.