BEUDAMED
    FDA Recall Terminated

    HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.

    Recall: Z-1046-05 · Initiated October 5, 2005

    Recall

    Recall Number
    Z-1046-05
    Event Number
    31445
    Firm
    Heartsine Technologies Inc
    FEI Number
    3004018643
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 5, 2005
    Posted
    July 28, 2005
    Terminated
    February 29, 2012
    Address
    940 Calle Amanecer, Ste E, San Clemente, CA, 92673-6218

    Description

    HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.

    Reason

    Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.

    Action

    AED software revision 1.0.20 and higher incorporate software enhancements to make the AED more forgiving for extreme variations in user technique. Firm will provide distributors with field correction notice dated 10/5/05. Customers to be notified by mid-October 2005.

    Distribution

    Nationwide, Puerto Rico, Argentina, Australia, Austria, Belgium, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Netherlands, Pakistan, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, UK

    Quantity

    1929 units