BEUDAMED
    FDA Recall Terminated

    Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally

    Recall: Z-1916-2010 · Initiated April 30, 2010

    Recall

    Recall Number
    Z-1916-2010
    Event Number
    55579
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 30, 2010
    Posted
    June 28, 2010
    Terminated
    December 10, 2012
    Address
    2301 5th Ave, Ste 200, Seattle, WA, 98121

    Description

    Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally

    Reason

    Seventeen AEDs failed production line testing (Final Acceptance Test).

    Action

    The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.

    Distribution

    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.

    Quantity

    205