Medical device recalls Moderate risk

EndoChoice, Inc. recalls Fuse 1C Colonoscope

Recall date
December 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0694-2016
FDA classification
Class II
Brand / firm
EndoChoice, Inc.
Sold / distributed
Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.

Why it was recalled

The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fuse 1C Colonoscope

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