BEUDAMED
    FDA Recall Terminated

    STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70

    Recall: Z-3178-2011 · Initiated July 7, 2011

    Recall

    Recall Number
    Z-3178-2011
    Event Number
    59331
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    July 7, 2011
    Posted
    September 12, 2011
    Terminated
    October 12, 2012
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70

    Reason

    Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.

    Action

    The recall communication was initiated on 7/8/11 and 7/11/11 with Biosense Webster forwarding A Customer Notification Letter, Acknowledgement Form and Software Release Note (Attachments 3, 4 and 1) via FedEx to all U.S. customers who purchased the Stockert 70 Radio Frequency Generator. Two letters and forms were sent to U.S. customers via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. The Release Note provides tips for the avoidance of potential events when working with the EP-SH UTTLE, STOCKERT 70, STOCKERT J50 or STOCKERT J70 RF generators with SW versions 1.035 / 1.035J /1.035J70 to 1.037/1.037J70.

    Distribution

    Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.

    Quantity

    3,397 units total (1,217 in U.S.)