BEUDAMED
    FDA Recall Terminated

    Heartstart HS1 Defibrillator Model M5068A

    Recall: Z-1196-2010 · Initiated November 2, 2009

    Recall

    Recall Number
    Z-1196-2010
    Event Number
    53816
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    NSA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 2, 2009
    Posted
    March 23, 2010
    Terminated
    May 23, 2013
    Address
    2301 5th Ave, Ste 200, Seattle, WA, 98121

    Description

    Heartstart HS1 Defibrillator Model M5068A

    Reason

    Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.

    Action

    The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.

    Distribution

    Worldwide Distribution.

    Quantity

    34 units distributed domestically