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Terminated

Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.

FDA Recall Z-0708-06 · Posted 2006-04-05

Recalling FirmFujinon Inc
Recall StatusTerminated
Product CodeFDF
Date Initiated2006-03-27
Date Terminated2007-12-03
Product Quantity2335 UNITS

Reason for Recall

Colonoscope insertion tube is not bending properly and is stiff.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041903FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5Fujinon, Inc. · 2004-11-10K944620SERIES 400 GASTROENTEROLOGY SYSTEMMarks & Murase · 1995-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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