BEUDAMED
    FDA Recall Terminated

    Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A

    Recall: Z-0641-2007 · Initiated February 28, 2007

    Recall

    Recall Number
    Z-0641-2007
    Event Number
    37477
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 28, 2007
    Posted
    March 22, 2007
    Terminated
    November 13, 2013
    Address
    2301 5th Ave, Ste 200, Seattle, WA, 98121

    Description

    Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A

    Reason

    Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation.

    Action

    On 02/28/2007 the firm sent letters via return receipt to all domestic and foreign customers. The letter advises the customer of the issue and if the user encounters the problem, to press the button again with additional force. In addition, the firm sent with the letter a new Quick Reference Card. Customers are instructed to replace the old Quick Reference Card with the new one which instructs them to press 'On' and 'Shock' buttons firmly.

    Distribution

    Distribution is worldwide. Devices are used by first responders (EMT, EMS, Fire and Police personnel, etc.), and by trained personnel on commercial airlines and business offices.

    Quantity

    9099 units