Capso Vision, Inc. recalls The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795…

Recall date

February 26, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2536-2020

FDA classification

Class II

Brand / firm

Capso Vision, Inc.

Sold / distributed

US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.

Why it was recalled

Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.