Reported May 27, 2020 · Terminated
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 -…
Capso Vision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Capso Vision, Inc. · 18805 Cox Ave Ste 250 · Saratoga, CA · 95070-6615
Is this the product you have?
- CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V
- DC/10mA REF 2795 - Product UsageThe 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
- Lot codes and dates
43 of 43 products
Products covered by this recall # Product as published 1 Lot Number: 02-18-0036 Serial Number and UDI Codes: A00ZD4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD4.699 2 A00ZJ2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ2.699 3 A00ZK2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK2.699 4 A00ZM0.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM0.699 5 A00ZM3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM3.699 6 A00ZN3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN3.699 7 A00ZQ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ5.699 8 A00ZW6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW6.699 9 A01004.699 0100867770000209 13180921 17200921 1002-18-0036 21A01004.699 10 A0100H.699 0100867770000209 13180921 17200921 1002-18-0036 21A0100H.699 11 A0102J.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102J.699 12 A0104G.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104G.699 13 A0104U.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104U.699 14 A00ZD6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD6.699 15 A00ZJ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ5.699 16 A00ZK4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK4.699 17 A00ZX4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX4.699 18 A010AA.699 0100867770000209 13180921 17200921 1002-18-0036 21A010AA.699 19 A00ZL7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL7.699 20 A00ZL8.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL8.699 - Amount recalled
- 44 units
Where it was sold
Why it was recalled
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
This product could cause temporary or reversible health problems — stop using it.
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