FDA-Device2021-12-22Class II

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Olympus Corporation of the Americas
Hazard

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

Sold states
US Nationwide distribution.
Affected count
14,447 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0379-2022

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