Device Recall EPShuttle/Stockert J50/Stockert J70

  • Model / Serial
    Software version: 1.035J
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA