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Terminated

Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

FDA Recall Z-1864-2016 · Posted None

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeFDT
Date Initiated2015-12-23
Date Terminated2018-01-18
Product Quantity94 units

Reason for Recall

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Firm Action

Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.

Root Cause

Other

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

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

Official Source

View FDA Recall →

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

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