BEUDAMED
    FDA Recall Terminated

    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.

    Recall: Z-0666-2007 · Initiated November 29, 2006

    Recall

    Recall Number
    Z-0666-2007
    Event Number
    36947
    Firm
    SuperDimension, Inc.
    FEI Number
    3004962788
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 29, 2006
    Posted
    March 29, 2007
    Terminated
    November 20, 2008
    Address
    161 Cheshire Lane North, Suite 100, Minneapolis, MN, 55441

    Description

    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.

    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.

    Distribution

    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.

    Quantity

    74 Bronchus Systems (37 US, 37 OUS)