BEUDAMED
    FDA Recall Terminated

    Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

    Recall: Z-2136-2008 · Initiated May 16, 2008

    Recall

    Recall Number
    Z-2136-2008
    Event Number
    48462
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LMC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2008
    Posted
    September 18, 2008
    Terminated
    October 10, 2008
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

    Reason

    The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".

    Action

    Consignees were notified by an Urgent Safety Notice letter on/about 05/16/2008. The letter provides the procedure the customer can follow to change the film calibration setting from "OFF" to "ON". The letter also provides information on how to get assistance from Agfa, if the customers prefer a service engineer perform the change. Consignees were instructed to send a copy of the letter or similar letter to their affected accounts. Agfa also offers to dispatch a service engineer to perform the parameter change.

    Distribution

    Worldwide Distribution --- USA including states of DE, FL, IL, KS, MA, MD, ME, MO, MT, NJ, NY, OH, OK, TX, UT, VA, WA, WV, and Puerto Rico and country of Canada.

    Quantity

    33 units