BEUDAMED
    FDA Recall Terminated

    CR DX-S, DX-S, Computed radiography system (Digitizer)

    Recall: Z-0855-06 · Initiated November 3, 2005

    Recall

    Recall Number
    Z-0855-06
    Event Number
    34776
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2005
    Posted
    May 9, 2006
    Terminated
    June 20, 2006
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    CR DX-S, DX-S, Computed radiography system (Digitizer)

    Reason

    Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

    Action

    Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.

    Distribution

    DC, MS, OR--three states

    Quantity

    3 units