BEUDAMED
    FDA Enforcement Class III Terminated

    Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

    Recall: Z-2152-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2152-2012
    Event ID
    62535
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Impact Instrumentation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 15, 2012
    Initiation Date
    March 19, 2012
    Classification Date
    August 7, 2012
    Termination Date
    August 15, 2012
    Address
    23 Fairfield Pl, West Caldwell, NJ, 07006-6206, United States

    Description

    Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

    Reason

    Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.

    Code Info

    Serial numbers: VCDB120315, VCDB120316, VCDB120299, VCDB120300, VCDB120313, VCDB120307, VCDB120312, VCDB120303, VCDB120310, VCDB120297.

    Distribution

    US Distribution to the state of Illinois.

    Quantity

    Ten Units