superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to pred

FDA device recall Z-0666-2007 · posted 2007-03-29 · Terminated

Recall details

Recalling firm

SuperDimension, Inc.

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.

Action taken

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

Status

Terminated

Product code

JAK

Quantity affected

74 Bronchus Systems (37 US, 37 OUS)

Distribution

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

Date initiated

2006-11-29

Date posted

2007-03-29

Date terminated

2008-11-20

Location

Minneapolis, MN

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