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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Boston Scientific iLab® 		see related information
Date Posted February 01, 2007
Recall Number Z-0395-2007
Product Boston Scientific brand iLab® Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS, Distributed by and Manufactured by: Boston Scientific Corporation IVUS, Technology Center, 47201 lakeview Parkway, Fremont, CA 94538
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Boston Scientific Target
47900 Bayside Parkway
Fremont, California 94538
For Additional Information Contact Tara Lopez
510-440-7874
Reason for
Recall		 The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
Action A customer notification was sent December 1, 2006 indicating the need for the correction.
Quantity in Commerce 24 units
Distribution Nationwide and Portugal.
 
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