BEUDAMED
    FDA Recall Terminated

    Philips Ingenuity Core 128 computed tomography x-ray system

    Recall: Z-0520-2018 · Initiated October 6, 2017

    Recall

    Recall Number
    Z-0520-2018
    Event Number
    78863
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 6, 2017
    Terminated
    July 2, 2019
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Philips Ingenuity Core 128 computed tomography x-ray system

    Reason

    Numerous issues related to software Brilliance iCT 4.1.6 software version.

    Action

    Philips Medical Systems (Cleveland), Inc. sent the Customer Information Letter via certified letters mail with returned receipts. Also, a Field Service Engineer will perform the software update on the system to resolve the issues. Implementation of the software update will be monitored.

    Distribution

    26 US Govt accounts