BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0

    Recall: Z-0064-06 · Initiated February 18, 2005

    Recall

    Recall Number
    Z-0064-06
    Event Number
    33488
    Firm
    Boston Scientific
    FEI Number
    3001236349
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 18, 2005
    Posted
    October 19, 2005
    Terminated
    January 30, 2006
    Address
    2710 Orchard Pkwy, San Jose, CA, 95134-2012

    Description

    Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0

    Reason

    The device has the potential for overheating its transformer and has the potential for fire hazard.

    Action

    The firm sent notification letters to its consignees on 2/18/05 and 5/18/05 via FedEx. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the PAM unit component.

    Distribution

    Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.