FDA Medical Device Recalls (openFDA)
Aizu Olympus Co., Ltd.: PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Recall number
- Z-0419-2024
- Recalling firm
- Aizu Olympus Co., Ltd.
- Product
- PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Status
- Open, Classified
- Initiated
- 2023-10-16
- Posted
- 2023-11-29
- Terminated
- not on file
- Reason
- Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
- Root cause
- Process control
- Action
- On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or Cynthia.Ow@Olympus.com.
- Quantity
- 24 incorrectly repaired units
- Distribution
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- Lot, serial or model codes
- UDI-DI 04953170305191 Serial Numbers 2302719, 2516751
- 510(k) numbers
- ["K131780"]
- PMA numbers
- not on file
- Product code
- FDF
- Firm FEI
- 3002964398
- Firm city
- Aizuwakamatsu
- Firm state
- 3 Chome
- Firm country
- Japan
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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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