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Terminated

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

FDA Recall Z-2778-2015 · Posted 2015-09-17

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeFDT
Date Initiated2015-06-30
Date Terminated2017-05-25
Product Quantity256 units

Reason for Recall

The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

Firm Action

FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.

Root Cause

Device Design

Distribution Pattern

Distributed in the US and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042076FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5Fujinon, Inc. · 2004-11-18K944620SERIES 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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