BEUDAMED
    FDA Enforcement Class III Terminated

    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

    Recall: Z-2243-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2243-2012
    Event ID
    62751
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    April 13, 2009
    Classification Date
    August 22, 2012
    Termination Date
    August 22, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    Description

    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

    Reason

    Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

    Code Info

    versions 2.4 and later

    Distribution

    Worldwide distribution: USA (nationwide) and country of: Bahamas.

    Quantity

    23 clients