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Capso Vision, Inc. recalls CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Produc
Recalled May 27, 2020 · FDA recall Z-2073-2020 · Capso Vision
Hazard
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. · FDA Class II
Units
44 units
Sold at
US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
Description
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Product
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is 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 →