Recall Z-3225-2017— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-3225-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-21

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2017-07-21, terminated 2018-07-12. It names one FDA 510(k) clearance: K152257. Product: 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: 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..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Terminated: 2018-07-12
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

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.

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