Recall Z-0694-2016— EndoChoice, Inc.

Name: FDA recall Z-0694-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Class II · Terminated

Class II FDA medical device recall by EndoChoice, Inc., initiated 2015-12-18, terminated 2016-03-24. It names one FDA 510(k) clearance: K141598. Product: Fuse 1C Colonoscope. Reason: The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma..

Recalling firm: EndoChoice, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Terminated: 2016-03-24
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K141598 — FUSE COLONOSCOPY SYSTEMEndochoice, Inc.·cleared 2014-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fuse 1C Colonoscope

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.