FDA recall Z-0379-2022

Olympus Corporation of the Americas · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2021-11-02
Report date: 2021-12-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

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