BEUDAMED
    FDA Recall Terminated

    MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021

    Recall: Z-1137-2008 · Initiated November 29, 2007

    Recall

    Recall Number
    Z-1137-2008
    Event Number
    45959
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 29, 2007
    Posted
    May 28, 2008
    Terminated
    September 17, 2010
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021

    Reason

    Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional

    Action

    On 11/29/07 Philips Medical Systems sent a letter dated 11/28/07 to customers stating that if users perform certain image file housekeeping operations, fluoroscopy cannot be performed and new exposures cannot be acquired until those operations are complete. It also instructs that the unavailability of fluoroscopy and exposure can be avoided by not pressing the "Delete All Images" button until any pending Autopush operation is complete. FCO 70800067 will be issued to service representatives to install new software.

    Distribution

    USA Distribution - CO, MN, NC, NJ and TX.

    Quantity

    9 units were distributed to hospitals in the US, 6 were installed, 3 were not installed or in use.