Apr

2006

Class II Boston Scientific Target

Company: Boston Scientific Target,
Date of Enforcement Report:3/15/2006
Class:lI

PRODUCT
ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0, Recall # Z-0789-06

REASON
Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only).

CODE
Serial number 4037; serial numbers 4041, 4020, 4056, 4018, 4037; serial number 4064; serial number 4022; serial numbers 4016, 4015, 4008, 4043

RECALLING FIRM/MANUFACTURER
Boston Scientific Target, Fremont, CA, by letters on March 6, and March 21, 2006, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
23 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Class II Boston Scientific Target

Amy Sellers

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