Recall Z-2622-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
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, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01,
| Date | Sep 25, 2025 (initiated Aug 15, 2025) |
| Status | Open, Classified |
| Reason | Potential for activation of an abnormal alarm pause. |
| Root cause | Software design |
| Action | 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 applicab |
| Quantity | 2,278 units |
| Distribution | Worldwide - Nationwide distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213799 | N Series Patient Monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Jul 12, 2022 |