BEUDAMED
    FDA Enforcement Class II Terminated

    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

    Recall: Z-0658-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0658-2013
    Event ID
    62950
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zoll Circulation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2013
    Initiation Date
    August 8, 2012
    Classification Date
    January 9, 2013
    Termination Date
    May 12, 2014
    Address
    650 Almanor Ave, Sunnyvale, CA, 94085-3513, United States

    Description

    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

    Reason

    Complaints associated with an unexpected stop in AutoPulse compressions.

    Code Info

    all

    Distribution

    Worldwide distribution.

    Quantity

    3881 in US, 1846 ROW.