BEUDAMED
    FDA Recall 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 · Initiated August 8, 2012

    Recall

    Recall Number
    Z-0658-2013
    Event Number
    62950
    Firm
    Zoll Circulation, Inc.
    FEI Number
    3003793491
    Product Code
    DRM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 8, 2012
    Posted
    January 9, 2013
    Terminated
    May 12, 2014
    Address
    650 Almanor Ave, Sunnyvale, CA, 94085-3513

    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.

    Action

    Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance.

    Distribution

    Worldwide distribution.

    Quantity

    3881 in US, 1846 ROW.