FDA-Device2015-10-07Class II

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Olympus Corporation of the Americas
Hazard

Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope

Sold states
Nationwide Distribution
Affected count
1014
Manufactured in
PO Box 610, 3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2818-2015

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