Mindray Patient Monitors and Telemetry Monitoring Systems
The ePM Series Patient Monitor has manual descriptions that may be insufficient or require clarification regarding alarm functions.
What happened
Mindray DS USA, Inc. began a recall on August 31, 2026, for certain patient monitors because operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. The recall was added to the FDA's Enforcement Report and classified on October 7, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
8 products
Compare these product details with yours, then check the recall notice for any restrictions.
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
BeneView Series. Operator's Manuals: T5 / T8
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Details
- Company began the recall
- Event ID
- 99828
- Company
- Mindray DS USA, Inc.
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
