FDA-Device2024-03-06Class II
Colonoscope, Model Number PCF-Q180AL.
Olympus Corporation of the Americas
Hazard
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Sold states
US Nationwide distribution.
Affected count
4
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Colonoscope, Model Number PCF-Q180AL.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1214-2024Don't want to check this manually?
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