Z-3128-2017Class II

Fujifilm Endoscope Model ED-530XT

Name: Z-3128-2017 Fujifilm Endoscope Model ED-530XT
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2015-03-09
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-03-09 / Terminated

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of 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... on 2015-03-09. FDA classified it as Class II and gives the reason as "Fujifilm is reporting a corrective action due to an FDA inspection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3128-2017
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Posted: 2017-09-13
Terminated: 2018-07-02
Recalling firm: FUJIFILM Healthcare Americas Corporation
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.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Fujifilm is reporting a corrective action due to an FDA inspection.
FDA root cause: Other
Action: Fujifilm notified their customers on 3/9/2015. Customers are advised of the updated manuals. and asked to destroyed existing manuals. Questions, comments and concerns should be directed to 800.385.4666 between the areas of 8:00 am and 5:00 pm EST or via email at [email protected].
Quantity in commerce: 260 manuals in total
Distribution: US Nationwide Distribution
Product codes and lots: For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3128-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3128-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3129-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

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)