superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
FDA Recall Z-0666-2007 · Posted 2007-03-29
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Recalling FirmSuperDimension, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2006-11-29
Date Terminated2008-11-20
Product Quantity74 Bronchus Systems (37 US, 37 OUS)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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