Olympus Corporation of the Americas recalls EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound

Recalled October 7, 2015 · FDA recall Z-2818-2015 · Olympus Corporation of the Americas

Hazard

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

Units

1014

Sold at

Nationwide Distribution

Description

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

Product

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.

Manufacturer(s)

Olympus Corporation of the Americas

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →