Company: Biosense Webster, Inc.
Date of Enforcement Report 9/21/11
Class ll:
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. Recall # Z-3178-2011
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letters on July 8, 2011 and July 11, 2011.
Manufacturer: Stockert Gmbh, Freiburg Im Breisgau, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,397 units
DISTRIBUTION
Nationwide and Internationally
