Home / Recalls / Medical Devices
Capso Vision, Inc. recalls The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795
Recalled July 15, 2020 · FDA recall Z-2536-2020 · Capso Vision
Hazard
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. · FDA Class II
Units
82
Sold at
US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.
Description
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.
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.
Manufacturer(s)
Capso Vision, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →