BEUDAMED
    FDA Recall Terminated

    Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option

    Recall: Z-0060-2008 · Initiated August 23, 2007

    Recall

    Recall Number
    Z-0060-2008
    Event Number
    39392
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 23, 2007
    Posted
    November 10, 2007
    Terminated
    September 27, 2010
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option

    Reason

    System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

    Action

    On 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem.

    Distribution

    Nationwide

    Quantity

    37 units