BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2622-2025 · Initiated August 15, 2025

    Recall

    Recall Number
    Z-2622-2025
    Event Number
    97437
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 15, 2025
    Posted
    September 25, 2025
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    Description

    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.

    Reason

    Potential for activation of an abnormal alarm pause.

    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 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.

    Distribution

    Worldwide - Nationwide distribution and the country of Canada.

    Quantity

    2,278 units