Recall Z-0666-2007 ยท JAK System, X-Ray, Tomography, Computed
SuperDimension, Inc.
superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
| Date | Mar 29, 2007 (initiated Nov 29, 2006) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |