FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
- Recall number
- Z-2706-2017
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
- Status
- Terminated
- Initiated
- 2017-02-17
- Posted
- not on file
- Terminated
- 2018-10-03
- Reason
- Fujifilm is recalling multiple endoscopes after a retrospective review.
- 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
- 4 units
- Distribution
- US Distribution to : AL, HI and MO
- Lot, serial or model codes
- 1U881A131 1U88A1A145 3U881A005
- 510(k) numbers
- ["K063847"]
- 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