Z-0112-2014Class II

Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral...

Name: Z-0112-2014 Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral...
Creator: Fujinon Inc
Published: 2013-07-31
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2013-07-31 / Terminated / root cause: manufacturing process

FDA source

Fujinon Inc began a recall of Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for... on 2013-07-31. FDA classified it as Class II and gives the reason as "A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0112-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-10-30
Terminated: 2014-03-04
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: The firm, FUJIFILM Medical Systems, USA, Inc. (FMSU-ESD) sent an "URGENT-MEDICAL DEVICE CORRECTION (UMDC)" and Customer Acknowledgement forms dated July 31, 2013 to their customers. The letter described the issue with the affected product; instructed customers on how to identify affected units; instructed customers to immediately cease use of the affected units; return affected units to FMSU-ESD for repairs and quality control inspection; and complete and return the attached "Customers Acknowledgement" form to FMSU-ESD, Attn: Regulatory Compliance, via fax to (973) 686-2616 or email: [email protected]. If you have any questions regarding this notice, please do not hesitate to contact Director, Quality and Regulatory Compliance, at (973) 686-2636 or by email: [email protected].
Quantity in commerce: 12 Units
Distribution: Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Product codes and lots: Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-29

Product code FDS

K120446Class IIFujinon/fujifilm Ultrasonic Endoscope Eg-530Ur2 and Eg-530Ut2Fujinon, Inc. / cleared 2012-08-13

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)