BEUDAMED
    FDA Recall Terminated

    ProxiDiagnost N90, UDI 706100

    Recall: Z-2256-2020 · Initiated April 23, 2020

    Recall

    Recall Number
    Z-2256-2020
    Event Number
    85603
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 23, 2020
    Terminated
    March 30, 2023
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    ProxiDiagnost N90, UDI 706100

    Reason

    The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.

    Action

    On April 23, 2020, the firm distributed Urgent Field Safety Notice letters to affected customers. Customers were informed of the product issue. According to the notice, the customer can use the system according to the IfU (Instruction for Use). The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately shut down the system according to IFU or (if present) use emergency off switch in room, remove patient, stop using the system for further examinations and contact customer service. Philips plans to perform an On-Site check of the SPDU thermo contact at affected systems, which will eliminate these issues. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70600101. If you need any further information or support concerning this issue, please contact your local Philips representative.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Chile and Germany.

    Quantity

    91