BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300

    Recall: Z-0112-06 · Initiated March 14, 2005

    Recall

    Recall Number
    Z-0112-06
    Event Number
    33446
    Firm
    Boston Scientific
    FEI Number
    3001236349
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 14, 2005
    Posted
    November 1, 2005
    Terminated
    December 13, 2005
    Address
    2710 Orchard Pkwy, San Jose, CA, 95134-2012

    Description

    Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300

    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 April 1, 2005. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the SAM unit.

    Distribution

    32 units have been distributed throughout the US, and 37 units distributed internationally.

    Quantity

    69 units distributed worldwide