FDA Medical Device Recalls (openFDA)
Boston Scientific Target: 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
- Recall number
- Z-0395-2007
- Recalling firm
- Boston Scientific Target
- 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
- Status
- Terminated
- Initiated
- 2006-12-01
- Posted
- 2007-02-01
- Terminated
- 2007-12-05
- Reason
- 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
- Other
- Action
- A customer notification was sent December 1, 2006 indicating the need for the correction.
- Quantity
- 24 units
- Distribution
- Nationwide and Portugal.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K051679"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28