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
