BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.

    Recall: Z-0283-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0283-2016
    Event ID
    72411
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 25, 2015
    Initiation Date
    September 1, 2015
    Classification Date
    November 17, 2015
    Termination Date
    December 15, 2020
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.

    Reason

    Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.

    Code Info

    Model # L9M2100

    Distribution

    Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.

    Quantity

    19