BeneVision N1 Patient Monitor: Potential Abnormal Alarm Pause
Mindray BeneVision N1 patient monitors may activate an abnormal alarm pause, potentially preventing critical alerts. Approximately 2,278 units distributed worldwide.
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: FDA Class II device with potential for harm (alarm failure could prevent critical patient alerts). No reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
Mindray DS USA is recalling certain BeneVision N1 Patient Monitor units due to a potential for abnormal alarm pause activation.
The BeneVision N1 is a bedside patient monitor used to display and record multiple physiological parameters. Approximately 2,278 units with specific serial numbers and software versions have been identified as affected.
The issue involves a potential malfunction where the alarm pause function could activate abnormally, preventing the device from alerting clinical staff to changes in patient conditions.
Affected users should contact Mindray for device evaluation. The recall affects N1 monitors with software versions 01.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01.
The recalled product
- Product
- BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Hazard
- alarm-pause
- software-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 01.05.00.01
- 01.06.00.01
- 01.06.01.01: 1. N1 Nellcor: Part Number: 6660E-PA00010
- Serial Numbers: AA3-06023768
- AA3-06023476
- AA3-03014849. 2. Used N1 Nellcor: Part Number: Q6660E-PA00010
- Serial Numbers: AA3-8C003924. 3. N1 Nellcor
- ST: Part Number: 6660E-PA00011
- Serial Numbers: AA3-92004799
- AA3-06023994
- AA3-03014853
- AA3-03014857
- AA3-03014701
- AA3-03014714
- AA3-03014848
- AA3-03014850
- AA3-03014861
- AA3-03014865
- AA3-04017814
- AA3-06024001
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03