BEUDAMED
    FDA Recall Terminated

    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

    Recall: Z-1464-2014 · Initiated March 6, 2014

    Recall

    Recall Number
    Z-1464-2014
    Event Number
    67763
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    March 6, 2014
    Posted
    April 16, 2014
    Terminated
    November 5, 2014
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

    Reason

    A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.

    Action

    .The firm, Phillips, sent an " URGENT Medical Device Correction" letter dated 2013 March 06, to its costumers . The letter disc ribes the product, problem and actions to be taken. The costumers were instructed to Verify that all planned image reconstructions are completed, and Perform off-line reconstructions if expected images are missing. The firm will release A Field Change Order (FCO) to correct the issue with software version release 3.5.7.and A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

    Distribution

    Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.

    Quantity

    116 units