Z-3225-2017Class II

FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract...

Name: Z-3225-2017 FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2017-07-21
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-07-21 / Terminated / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and... on 2017-07-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3225-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Posted: 2017-09-27
Terminated: 2018-07-12
Recalling firm: FUJIFILM Healthcare Americas Corporation
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.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
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.
Root cause tag: design
FDA root cause: Device Design
Action: On July 21, 2017, Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division distributed Urgent Medical Device Correction and Removal notices & Field Action Verification Forms to their U.S. Consignees by USPS certified mail. Fujifilm Medical Systems will contact all customers that have the duodenoscope by October 2017, with details for returning the device for replacement parts. This field action allows continued use of the current device until you are contacted by a sales representative for replacement parts as early as October 2017. While the remediation of the scopes will take approximately two weeks to complete, Fujifilm Medical Systems U.S.A. Inc. Endoscopy Division will provide interim duodenoscopes on loan for continuity of care. Once received, the recalling firm will replace the forceps elevator mechanism with O-ring and the distal end cap. An updated manual has been generated to include new information/guidance. Customers are encouraged to complete and return the Field Action Verification Form via email to [email protected] or via fax to (973) 872-4723. Customers with questions can call Larry Picciano, Sr. Director Quality and Regulatory Affairs at (973) 686-2479.
Quantity in commerce: 362 units
Distribution: Nationwide
Product codes and lots: All lots/serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3225-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3225-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27

Product code FDT

K152257Class IIFujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. / cleared 2017-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)