BEUDAMED
    FDA Recall Terminated

    Stockert 70 Radio Frequency Ablation Generator

    Recall: Z-1328-04 · Initiated July 16, 2004

    Recall

    Recall Number
    Z-1328-04
    Event Number
    29591
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2004
    Posted
    August 7, 2004
    Terminated
    May 7, 2012
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    Stockert 70 Radio Frequency Ablation Generator

    Reason

    Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.

    Action

    Customers were instructed to suspend use of the generators with software version 1.033 until they are upgraded with version 1.034B in a letter dated 7/15/2004. Firm issued a second letter on 9/17/04 for a software error discovered in-house during the upgrade. It instructs a workaround solution to prevent unwanted activity of the catheter.

    Distribution

    Nationwide

    Quantity

    unknown, not stated.