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
FDA Recall Z-0395-2007 · Posted 2007-02-01
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Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeDQO
Date Initiated2006-12-01
Date Terminated2007-12-05
Product Quantity24 units
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.
Firm Action
A customer notification was sent December 1, 2006 indicating the need for the correction.
Root Cause
Other
Distribution Pattern
Nationwide and Portugal.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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