Capso Vision, Inc. recalls CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Produ…
- Recall date
- July 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2073-2020
- FDA classification
- Class II
- Brand / firm
- Capso Vision, Inc.
- Sold / distributed
- US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
Why it was recalled
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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