Events

Recall of Device Recall Boston Scientific iLab

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Target.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37126
  • Event Risk Class
    Class 2
  • Event Number
    Z-0395-2007
  • Event Initiated Date
    2006-12-01
  • Event Date Posted
    2007-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49950
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    ultrasound - Product Code DQO
  • 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.
  • Action
    A customer notification was sent December 1, 2006 indicating the need for the correction.

Device

Device Recall Boston Scientific iLab
  • Model / Serial
    All serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Portugal.
  • Product Description
    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
  • Manufacturer
    Boston Scientific Target

Manufacturer

Boston Scientific Target
  • Manufacturer Address
    Boston Scientific Target, 47900 Bayside Parkway, Fremont CA 94538
  • Source
    USFDA