Mindray BeneVision Distributed Monitoring System Recalled for Intermittent Freezes
Mindray is recalling 1,938 BeneVision Distributed Monitoring Systems because they may intermittently freeze, causing telemetry data to stop communicating to the central system.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may fail to transmit patient data, creating a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 1,938 units of the BeneVision Distributed Monitoring System (DMS). The recall affects specific hardware part numbers (115-051209-00, 115-034414-00, and 115-034413-00) when used with software versions 03.04.00, 04.01.00, 04.03.00, 04.04.00, or 04.04.01. The affected systems were distributed nationwide and in Canada.
The recall is due to a defect where the system may intermittently freeze and require a manual reboot to resume normal operation. If a freeze occurs, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Mindray for instructions on how to resolve the issue, which may involve software updates or hardware replacement.
The recalled product
- Product
- Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- Affected units
- 1,938
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Mindray DS USA, Inc. dba Mindray North America
See all →- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- HighAnesthesia vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighIsoflurane vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighPatient monitors recalled over potential activation of an abnormal alarm pause
FDA (Devices) · 2025-10-01
- HighSevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction
FDA (Devices) · 2024-09-11
Same hazard · software freeze
See all →- ModerateRadiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
FDA (Devices) · 2025-04-30
- SevereTANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA (Devices) · 2022-10-05
- ModerateuMI 550 PET Imaging System Software Workflow May Occasionally Freeze
FDA (Devices) · 2021-10-06
- ModerateuEXPLORER PET/CT System Workflow Freeze Recall
FDA (Devices) · 2021-10-06
- ModeratePhilips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues
FDA (Devices) · 2017-03-22