Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage

FDA Recall #Z-1863-2016 — Class II — December 23, 2015

Recall #Z-1863-2016 Date: December 23, 2015 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Fujifilm Medical Systems U.S.A., Inc. — Wayne, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

484 units

Distribution

Nationwide Distribution.

Code Information

All distribution dates :3/2003-4/2016

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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