Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video en
FDA device recall Z-0708-06 · posted 2006-04-05 · Terminated
Recall details
- Recalling firm
- Fujinon Inc
- Reason for recall
- Colonoscope insertion tube is not bending properly and is stiff.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FDF
- Quantity affected
- 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 Pendlet
- Date initiated
- 2006-03-27
- Date posted
- 2006-04-05
- Date terminated
- 2007-12-03
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 (K041903) | Fujinon, Inc. | 2004-11-10 |
| SERIES 400 GASTROENTEROLOGY SYSTEM (K944620) | Marks & Murase | 1995-04-27 |