BEUDAMED
    FDA Recall Terminated

    IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.

    Recall: Z-1245-2008 · Initiated June 28, 2007

    Recall

    Recall Number
    Z-1245-2008
    Event Number
    46386
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 28, 2007
    Posted
    September 11, 2008
    Terminated
    March 3, 2011
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.

    Reason

    Text and Images may not be synchronized.

    Action

    AGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in the software.

    Distribution

    U.S. Nationwide and Canada

    Quantity

    154 units