BEUDAMED
    FDA Recall Terminated

    RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649

    Recall: Z-0087-04 · Initiated October 6, 2003

    Recall

    Recall Number
    Z-0087-04
    Event Number
    27500
    Firm
    Rita Medical Systems
    FEI Number
    1000523114
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2003
    Posted
    November 1, 2003
    Terminated
    May 5, 2004
    Address
    967 N Shoreline Blvd, Mountain View, CA, 94043-1932

    Description

    RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649

    Reason

    The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.

    Action

    On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.

    Quantity

    137 + 225 units (lot Y082003)