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Evis Exera II Colonovideoscope Olympus Pcf Type Q180AL

by Olympus Medical Systems Corporation 3 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

7 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170202544 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

9 recalls · 7 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1208-2024 FDA Class II initiated 11 Jan 2024
    • Ongoing Z-1205-2024 FDA Class II initiated 11 Jan 2024
    • Ongoing Z-1209-2024 FDA Class II initiated 11 Jan 2024
    • Ongoing Z-1214-2024 FDA Class II initiated 11 Jan 2024

    Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

  • 2 recalls, same reason

    • Ongoing Z-0329-2024 FDA Class II initiated 25 Sep 2023 on shared 510(k) K100584
    • Ongoing Z-0334-2024 FDA Class II initiated 25 Sep 2023

    Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

    • Ongoing Z-1132-2023 FDA Class II initiated 21 Dec 2022

    A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

    • Terminated Z-1274-2022 FDA Class II initiated 22 Apr 2022

    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

    • Terminated Z-1009-2019 FDA Class II initiated 17 Dec 2018

    The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Evis Exera II Colonovideoscope
Generic Name
Flexible video colonoscope, reusable
Model / Reference
OLYMPUS PCF TYPE Q180AL
Primary DI / UDI-DI
04953170202544
FDA Product Code
NWB, FDS, FDF
GMDN Term
Flexible video colonoscope, reusable
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K100584)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No