BEUDAMED
    FDA Enforcement Class II 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 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2061-2015
    Event ID
    71606
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 22, 2015
    Initiation Date
    June 26, 2015
    Classification Date
    July 13, 2015
    Termination Date
    January 27, 2016
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    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.

    Code Info

    N/A

    Distribution

    Distributed in the state of MO.

    Quantity

    2