BEUDAMED
    FDA Recall Terminated

    Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option

    Recall: Z-1353-06 · Initiated July 1, 2006

    Recall

    Recall Number
    Z-1353-06
    Event Number
    35838
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2006
    Posted
    August 3, 2006
    Terminated
    May 21, 2008
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option

    Reason

    Potential for measurements, lines, texts, etc to be stored incorrectly.

    Action

    On 7/1/06 the firm issued a letter to consignees stating the problem and how to prevent the problem. The firm reports a software update will be issued no later than September 2006 to correct the problem.

    Distribution

    Nationwide.

    Quantity

    157 devices