STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/a

FDA device recall Z-3178-2011 · posted 2011-09-12 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

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.

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

LPB

Quantity affected

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,

Date initiated

2011-07-07

Date posted

2011-09-12

Date terminated

2012-10-12

Location

Irwindale, CA