BEUDAMED
    FDA Recall Terminated

    Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.

    Recall: Z-0899-2013 · Initiated December 19, 2012

    Recall

    Recall Number
    Z-0899-2013
    Event Number
    64389
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 19, 2012
    Posted
    February 28, 2013
    Terminated
    December 3, 2013
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.

    Reason

    The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.

    Action

    Philips Healthcare sent an Urgent - Medical Device Correction letter dated December 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to have BioMedical Engineering personnel inspect the patient table top screws that secure it to the carrier. Customers were instructed that If it is found that the table top screws are improperly seated, they should stop using the system and contact their local Philips Field Service Engineer for repair. A Philips Field Service Engineer will schedule a time to inspect and repair all the affected systems. For further information customers were instructed to contact their Philips Healthcare Customer Care Solutions Center at 1-800-722-9377 and follow the recorded menu option to reach a Customer Solutions. For questions regarding this recall call 800-722-9377, ext 5.

    Distribution

    Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA.

    Quantity

    412 Units