BEUDAMED
    FDA Enforcement Class II Terminated

    Sunquest Laboratory, version 7.0 not available

    Recall: Z-0250-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0250-2013
    Event ID
    63369
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    November 3, 2011
    Classification Date
    November 6, 2012
    Termination Date
    November 6, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    Description

    Sunquest Laboratory, version 7.0 not available

    Reason

    Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

    Code Info

    not available

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Ireland

    Quantity

    14 sites