EndoChoice Recalls Fuse 1C Colonoscopes Due to Bending Section Separation Risk

Plain-English summary

EndoChoice, Inc. is recalling 253 units of the Fuse 1C Colonoscope. The recall involves specific item and model numbers, including FSC-3300-SL (Model C38s), FSC-330-C6333 (Model C38s-150), FSC-3300-ST (Model F1C), FSC330-A6334 (Model F1C-MC90), FDC-3300-133 (Model Fuse Colo 133), and FSC-3300-150 (Model Fuse Colo 150). The devices were distributed worldwide, including in the United States, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain, and Switzerland.

The recall was initiated because the bending section of the device may partially separate from the insertion tube. This defect creates a potential for tissue trauma during use. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and distributors should identify the affected units by checking the serial numbers listed in the official recall notice. Patients who have undergone procedures using these devices should contact their healthcare provider if they have concerns or experience symptoms related to the procedure. The recalling firm, EndoChoice, Inc., is responsible for managing the recall and providing further instructions to affected parties.

The recalled product

Product

Fuse 1C Colonoscope

Manufacturer

EndoChoice, Inc.

Category

Medical Device — Endoscopy

Hazard

• tissue-trauma
• mechanical-failure

Affected units

253

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls