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U.S. Department of Health and Human Services

Class 2 Device Recall superDimension Bronchus System

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  Class 2 Device Recall superDimension Bronchus System see related information
Date Initiated by Firm November 29, 2006
Date Posted March 29, 2007
Recall Status1 Terminated 3 on November 20, 2008
Recall Number Z-0667-2007
Recall Event ID 36947
Product Classification endoscopic loacalization system accessories - Product Code JAK
Product Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
Code Information All codes of disposable system components (Locatable Guide and Extended Working Channel).
Recalling Firm/
Manufacturer		 SuperDimension, Inc.
161 Cheshire Lane North, Suite 100
Minneapolis MN 55441
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce Up to 2,000 each Locatable Guide Kit and Extended Working Channel
Distribution Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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