Z-0395-2007

Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS...

Name: Z-0395-2007 Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS...
Creator: Boston Scientific Target
Published: 2006-12-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-12-01 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Target began a recall of Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use; Model Number(s): iLab120lNS, iLab2401NS, Distributed by and Manufactured by... on 2006-12-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0395-2007
Status: Terminated
Initiated: 2006-12-01
Posted: 2007-02-01
Terminated: 2007-12-05
Recalling firm: Boston Scientific Corporation
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
Product code: DQO Catheter, Intravascular, Diagnostic
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A customer notification was sent December 1, 2006 indicating the need for the correction.
Quantity in commerce: 24 units
Distribution: Nationwide and Portugal.
Product codes and lots: All serial numbers.

Product code DQO

K051679Class IIIlab Ultrasound Imaging SystemBoston Scientific Corp / cleared 2005-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)