Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0694-2016 — Fuse 1C Colonoscope

U.S. FDA — Device Enforcement · United States · 2015-12-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0694-2016
Date of alert
2015-12-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
EndoChoice, Inc.
Product category
device
Product type
Devices
Reported risk: The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.