FDA Medical Device Recalls (openFDA)
Fujinon Inc: 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.
- Recall number
- Z-0112-2014
- Recalling firm
- Fujinon Inc
- 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.
- Status
- Terminated
- Initiated
- 2013-07-31
- Posted
- 2013-10-30
- Terminated
- 2014-03-04
- Reason
- 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
- 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: gwalljasper@fujifilm.com. 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: gwalljasper@fujifilm.com.
- Quantity
- 12 Units
- Distribution
- Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
- Lot, serial or model codes
- Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
- 510(k) numbers
- ["K120446"]
- PMA numbers
- not on file
- Product code
- FDS
- Firm FEI
- 2431293
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28