FDA Medical Device Recalls (openFDA)
Integrated Medical Systems Inc: Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
- Recall number
- Z-0910-2016
- Recalling firm
- Integrated Medical Systems Inc
- Product
- Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
- Status
- Terminated
- Initiated
- 2016-01-20
- Posted
- not on file
- Terminated
- 2016-10-13
- Reason
- If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
- Root cause
- Nonconforming Material/Component
- Action
- The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.
- Quantity
- 1 instrument
- Distribution
- Distributed US (nationwide) and in Australia.
- Lot, serial or model codes
- Serial Number 240T024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCQ
- Firm FEI
- 3010663403
- Firm city
- Birmingham
- Firm state
- AL
- 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