Recall Z-0109-2027 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc.
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
| Date | Oct 7, 2026 (initiated Aug 31, 2026) |
| Status | Open, Classified |
| Reason | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| Root cause | Labeling design |
| Action | Mindray notified consignees on about 08/31/2026 via "URGENT: Medical Device Recall" letter. Consignees were informed that Mindray was providing updated instructions regarding physiological alarms in certain Mindray patient monitoring device Instructions for Use (IFU)/Operator s Manuals. This action is limited to updates to the IFU/Operators Manual content and does not require removal, return, repair, or replacement of the monitors. Consignees were instructed to continue using the Mindray monitors associated with the affected operator s manual, ensure that applicable clinical staff are made |
| Quantity | 32,184 units |
| Distribution | Worldwide - Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 1 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., May 20, 2026 |