Recall Z-0708-06 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Fujinon Inc
Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
| Date | Apr 5, 2006 (initiated Mar 27, 2006) |
| Status | Terminated |
| Reason | Colonoscope insertion tube is not bending properly and is stiff. |
| Root cause | Other |
| Action | Fujinon sent out a Technical Bulletin on 3/27/2006 that instructs the physician to do a bending test with the colonoscope. If the scope does not bend around an 8 inch bending diameter, the scope is not to be used. |
| Quantity | 2335 UNITS |
| Distribution | Product is distributed nationwide to hospitals and physicians. It was shipped internationally to Canada. US Government accounts include VA medical centers in Spokane WA, St. Louis, MO and Camp Pendleton Naval Hospital in Camp Pendleton, CA. |
| FDA record | Open on fda.gov |