BEUDAMED
    FDA Recall Terminated

    HeartStart FR2+ Defibrillator

    Recall: Z-0308-2007 · Initiated December 19, 2006

    Recall

    Recall Number
    Z-0308-2007
    Event Number
    36662
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 19, 2006
    Posted
    December 27, 2006
    Terminated
    June 22, 2011
    Address
    2301 5th Ave, Ste 200, Seattle, WA, 98121

    Description

    HeartStart FR2+ Defibrillator

    Reason

    Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation

    Action

    On 12/19/06 the firm sent letters via return receipt to all domestic customers. The letter advised customers of the issue and if the user encounters the problem, to press the button again with additional force. The users are to contact Philips for replacement. The devices can be used until the user receives a replacement.

    Distribution

    Distribution is worldwide.

    Quantity

    2000 units