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, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

Potential for activation of an abnormal alarm pause.

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.