Events

Recall of Device Recall superDimension Bronchus System

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

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
    36947
  • Event Risk Class
    Class 2
  • Event Number
    Z-0667-2007
  • Event Initiated Date
    2006-11-29
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49654
  • 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
    endoscopic loacalization system accessories - Product Code JAK
  • Reason
    The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superdimension bronchus system was used. the biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
  • Action
    An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.

Device

Device Recall superDimension Bronchus System
  • Model / Serial
    All codes of disposable system components (Locatable Guide and Extended Working Channel).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
  • Manufacturer
    SuperDimension, Inc.

Manufacturer

SuperDimension, Inc.
  • Manufacturer Address
    SuperDimension, Inc., 161 Cheshire Lane North, Suite 100, Minneapolis MN 55441
  • Source
    USFDA