BEUDAMED
    FDA Recall Terminated

    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

    Recall: Z-2114-2016 · Initiated June 21, 2016

    Recall

    Recall Number
    Z-2114-2016
    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

    Ingenuity Core 128, model #728323; 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 causing injury to patients, operators, by-standers and 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

    14 units