BEUDAMED
    FDA Recall Terminated

    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

    Recall: Z-2111-2016 · Initiated June 21, 2016

    Recall

    Recall Number
    Z-2111-2016
    Event Number
    74511
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 21, 2016
    Terminated
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

    Reason

    Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.

    Action

    Philips is informing the consignee of this issue through: Customer Information Letter (CIL) 72800656 . International consignees will be contacted by Philips Healthcare Global Market representatives, who will distribute the CIL. A Field Service Engineer (FSE) will contact the customers to schedule a time to conduct the appropriate correction through Field Change Order (FCO) 72800656 once it is available. This FCO will address the above identified issue. A response form sent to the customer via certified mail. This package will also contain a return receipt.

    Distribution

    Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

    Quantity

    3 units