Mahwah, NJ, United States
Mindray DS USA, Inc. recalls
1 recall recorded since 2018, most recently on 31 August 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 31 August 2026
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0109-2027, Z-0110-2027, Z-0112-2027, Z-0111-2027, Z-0115-2027, Z-0113-2027, Z-0116-2027, Z-0114-2027
- ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
- BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
- Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
- BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
- cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
- BeneView Series. Operator's Manuals: T5 / T8
- T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
- Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.