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U.S. Department of Health and Human Services

Class 2 Device Recall EPShuttle/Stockert J50/Stockert J70

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 Class 2 Recall
EPShuttle/Stockert J50/Stockert J70
see related information
Date Posted September 12, 2011
Recall Status1 Terminated on October 12, 2012
Recall Number Z-3178-2011
Recall Event ID 59331
Premarket Approval
PMA Number
P990071
Product Classification Cardiac Ablation Percutaneous Catheter - Product Code LPB
Product 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
Code Information Software version: 1.035J
Recalling Firm/
Manufacturer
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale, California 91706-2006
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
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.
Quantity in Commerce 3,397 units total (1,217 in U.S.)
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LPB and Applicant = BIOSENSE WEBSTER, INC.
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