BEUDAMED
    FDA Recall Terminated

    Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

    Recall: Z-1904-2011 · Initiated January 28, 2008

    Recall

    Recall Number
    Z-1904-2011
    Event Number
    58099
    Firm
    Zoll Circulation, Inc.
    FEI Number
    3003793491
    Product Code
    DRM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2008
    Posted
    April 7, 2011
    Terminated
    April 28, 2011
    Address
    650 Almanor Ave, Sunnyvale, CA, 94085-3513

    Description

    Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

    Reason

    Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).

    Action

    The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.

    Distribution

    Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.

    Quantity

    not provided