FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Colonovideoscope Model CF-H180AL
- Recall number
- Z-1274-2022
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Colonovideoscope Model CF-H180AL
- Status
- Terminated
- Initiated
- 2022-04-22
- Posted
- not on file
- Terminated
- 2024-03-13
- Reason
- A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
- Root cause
- Nonconforming Material/Component
- Action
- Olympus issued letter via e-mail on April 22, 2022. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide a service loaner device in an effort to not disrupt patient care. Contact: 647-999-3203 or at Cynthia.Ow@Olympus.com
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Lot, serial or model codes
- UDI-DI: 04953170339615 Serial number: 2501131
- 510(k) numbers
- ["K100584"]
- PMA numbers
- not on file
- Product code
- FDF
- 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