BEUDAMED
    FDA Recall Terminated

    Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).

    Recall: Z-0641-05 · Initiated February 14, 2005

    Recall

    Recall Number
    Z-0641-05
    Event Number
    31212
    Firm
    Heartsine Technologies Inc
    FEI Number
    3004018643
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 14, 2005
    Posted
    March 23, 2005
    Terminated
    June 8, 2011
    Address
    940 Calle Amanecer, Ste E, San Clemente, CA, 92673-6218

    Description

    Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).

    Reason

    The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.

    Action

    Recall was initiated by telephone 2/14/2005 with follow-up fax, email or postal mailing using one of several customized letters for distributors or customers. Customers will be sent an upgrade kit by overnite mail and forms to confirm upgrade.

    Distribution

    Nationwide to distributors and user facilities. Also to Argentina, Austria, Belgium, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Thailand, United Kingdom.

    Quantity

    672