Recall Z-3128-2017— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-3128-2017
Creator: U.S. Food and Drug Administration
Published: 2015-03-09

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2015-03-09, terminated 2018-07-02. It names one FDA 510(k) clearance: K152257. Product: Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.. Reason: Fujifilm is reporting a corrective action due to an FDA inspection..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Terminated: 2018-07-02
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K152257 — Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc.·cleared 2017-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

Reason for recall

Fujifilm is reporting a corrective action due to an FDA inspection.

Data sourced from openFDA. This site is unofficial and independent of the FDA.