Home / Recalls / Fujifilm Medical Systems U.S.A., Inc. / Z-3225-2017

Z-3225-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
July 21, 2017
Termination Date
July 12, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
362 units

Product Description

FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Reason for Recall

An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.

Distribution Pattern

Nationwide

Code Information

All lots/serial numbers

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