FDA-Device2016-02-03Class II
Fuse 1C Colonoscope
EndoChoice, Inc.
Hazard
The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
Sold states
Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.
Affected count
253 units
Manufactured in
11810 Wills Rd Ste 100, ATTN: Theron Gober, Alpharetta, GA, United States
Products
Fuse 1C Colonoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0694-2016Don't want to check this manually?
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