Fuse 1C Colonoscope
FDA device recall Z-0694-2016 · posted 2016-01-27 · Terminated
Recall details
- Recalling firm
- EndoChoice, Inc.
- Reason for recall
- The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FDF
- Quantity affected
- 253 units
- Distribution
- Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.
- Date initiated
- 2015-12-18
- Date posted
- 2016-01-27
- Date terminated
- 2016-03-24
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUSE COLONOSCOPY SYSTEM (K141598) | Endochoice, Inc. | 2014-09-30 |