FDA Medical Device Recalls (openFDA)
Olympus America Inc.: EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
- Recall number
- Z-2807-2015
- Recalling firm
- Olympus America Inc.
- Product
- EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
- Status
- Terminated
- Initiated
- 2015-03-26
- Posted
- 2015-09-22
- Terminated
- 2017-02-01
- Reason
- New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
- Root cause
- Labeling design
- Action
- The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning instructions when the new brushes arrive on/about May 8, 2015. If you have question, contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, Monday-Friday between 7 AM EST - 8 PM EST. For additional information on this matter, contact V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or by email at laura.storms@olympus.com.
- Quantity
- 6109
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
- Lot, serial or model codes
- Model: TJF-Q180V, all sold units
- 510(k) numbers
- ["K080403"]
- PMA numbers
- not on file
- Product code
- FDT
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- 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