Z-2706-2017Class II

Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic...

Name: Z-2706-2017 Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2017-02-17
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-02-17 / Terminated

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs on 2017-02-17. FDA classified it as Class II and gives the reason as "Fujifilm is recalling multiple endoscopes after a retrospective review". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2706-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-17
Posted: 2017-07-10
Terminated: 2018-10-03
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: Fujifilm is recalling multiple endoscopes after a retrospective review.
FDA root cause: Other
Action: Fujifilm sent an Urgent - Medical Device Removal letter dated February 17, 2017. Customers are provided information regarding the recall and asked to complete the attached form and return to Fujifilm. Questions can be directed to sales representative. For further questions, please call (973) 709-2202.
Quantity in commerce: 4 units
Distribution: US Distribution to : AL, HI and MO
Product codes and lots: 1U881A131 1U88A1A145 3U881A005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2706-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2706-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10

Product code FDS

K063847Class IIFujinon Ultrasonic Endoscope and Processor, Models Eg-530Ur, Eg-530Ut and Su-700Fujinon, Inc. / cleared 2007-03-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)