FDA-Device2022-05-11Class II
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas
Hazard
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Sold states
Nationwide
Affected count
731 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1034-2022Don't want to check this manually?
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