BEUDAMED
    FDA Recall Terminated

    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

    Recall: Z-2061-2015 · Initiated June 26, 2015

    Recall

    Recall Number
    Z-2061-2015
    Event Number
    71606
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2015
    Posted
    July 13, 2015
    Terminated
    January 27, 2016
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

    Reason

    Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.

    Action

    PRB0046372 was created to address the corrective actions related to this issue. On 6/26/2015, an email communication, as an effectiveness check was sent to the two customers. Acknowledgment, via email, that the communication was received was requested from the consignees.

    Distribution

    Distributed in the state of MO.

    Quantity

    2