Company: Capso Vision, Inc.
Date of Enforcement Report: 7/15/2020
Class II

PRODUCT

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.

Recall Number: Z-2536-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Capso Vision, Inc. on 2/26/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

82

DISTRIBUTION

U.S. Nationwide