Skip to content
Recall Observatory FDA recall evidence

Device product

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Z-2467-2023

July 27, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92703
Status
Ongoing
Classification
Class II
Quantity
6,426 units
Official record key
device-enforcement:Z-2467-2023

Official wording

Reason: Recent reports of patient infection.

Code information: Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recent reports of patient infection.