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Terminated

Fuse 1C Colonoscope

FDA Recall Z-0694-2016 · Posted 2016-01-27

Recalling FirmEndoChoice, Inc.
Recall StatusTerminated
Product CodeFDF
Date Initiated2015-12-18
Date Terminated2016-03-24
Product Quantity253 units

Reason for Recall

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

Firm 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.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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