Device product

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

Z-1864-2016

December 23, 2015

Class II

Product summary

Firm: Fujifilm Medical Systems U.S.A., Inc.
Event: Event 73469
Status: Terminated
Classification: Class II
Quantity: 94 units
Official record key: device-enforcement:Z-1864-2016

Official wording

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

Code information: All distribution dates :3/2003-4/2016

Distribution pattern: Nationwide Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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