BEUDAMED
    FDA Recall Terminated

    Philips Easy Diagnost Eleva

    Recall: Z-0910-2007 · Initiated July 23, 2007

    Recall

    Recall Number
    Z-0910-2007
    Event Number
    44910
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 23, 2007
    Posted
    September 25, 2007
    Terminated
    September 17, 2012
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Philips Easy Diagnost Eleva

    Reason

    Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.

    Action

    On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.

    Distribution

    Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.

    Quantity

    289 units