Events

Recall of Device Recall 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
    34951
  • Event Risk Class
    Class 2
  • Event Number
    Z-0789-06
  • Event Initiated Date
    2006-03-06
  • Event Date Posted
    2006-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44992
  • 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
    Utrasound Imaging System - Product Code DQO
  • Reason
    Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ice intracardiac imaging catheters only).
  • Action
    The firm initiated recall actions on March 6, 2006. On March 21, 2006, the firm issued notification letters to all appropriate personnel at hospitals and user facilities to inform them of actions taken by Boston Scientific to remediate any risks.

Device

Device Recall iLab
  • Model / Serial
    Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 13 US consignees and 10 foreign consignees.
  • Product Description
    iLab Utrasound Imaging System, software controlled Imaging Catheter.
  • Manufacturer
    Boston Scientific Target

Manufacturer

Boston Scientific Target
  • Manufacturer Address
    Boston Scientific Target, 4701 Lakeview Blvd, Fremont CA 94537
  • Source
    USFDA