Recall Z-0694-2016 ยท FDF Colonoscope And Accessories, Flexible/Rigid
EndoChoice, Inc.
Fuse 1C Colonoscope
| Date | Jan 27, 2016 (initiated Dec 18, 2015) |
| Status | Terminated |
| Reason | The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma. |
| Root cause | Process design |
| Action | Consignees were notified on12/09/2015 that a sales representative would be contacting them to facilitate the exchange of the colonsocope and the defective device will be returned to EndoChoice. |
| Quantity | 253 units |
| Distribution | Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141598 | FUSE COLONOSCOPY SYSTEM Endochoice, Inc., Sep 30, 2014 |