BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00
FDA device recall Z-2622-2025 · posted 2025-09-25 · Open, Classified
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- Potential for activation of an abnormal alarm pause.
- Action taken
- Mindray contacted consignees via letter on about 08/15/2025. consignees were instructed that they may continue to use the BeneVision N1 patient monitor as a multi-parameter module with Mindray host monitors. Per the additional guidance, it is recommended to confirm that the remaining alarm time counter is actively displayed and follows the existing N1 Operator's Manual: Instructions for when the Alarm Pause is Activated. An image was also included in the notification letter showing the correctly displayed Alarm Pause notification and timer. Consignees were also requested to make all applicable clinical staff aware of the issue and to complete and return the Acknowledgement and Receipt form. Mindray's Care team will deploy a software update to correct the issue. Distributors were advised to contact their direct customers and notify them directly.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 2,278 units
- Distribution
- Worldwide - Nationwide distribution and the country of Canada.
- Date initiated
- 2025-08-15
- Date posted
- 2025-09-25
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| N Series Patient Monitors (K213799) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-07-12 |