FDA-Device2016-03-02Class II
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Integrated Medical Systems Inc
Hazard
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Sold states
Distributed US (nationwide) and in Australia.
Affected count
122 instruments
Manufactured in
3200 2nd Ave N, N/A, Birmingham, AL, United States
Products
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0901-2016Don't want to check this manually?
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