Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
FDA Recall Z-1861-2016 · Posted None
Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeFDT
Date Initiated2015-12-23
Date Terminated2018-01-18
Product Quantity98 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.