medical Class II Updated 2020-05-27

Capso Vision, Inc. recalls CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireles

Recalled 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.

Hazard / Issue

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 02-18-0036 Serial Number and UDI Codes: A00ZD4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD4.699; A00ZJ2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ2.699; A00ZK2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK2.699; A00ZM0.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM0.699; A00ZM3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM3.699; A00ZN3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN3.699; A00ZQ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ5.699; A00ZW6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW6.699; A01004.699 0100867770000209 13180921 17200921 1002-18-0036 21A01004.699; A0100H.699 0100867770000209 13180921 17200921 1002-18-0036 21A0100H.699; A0102J.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102J.699; A0104G.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104G.699; A0104U.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104U.699; A00ZD6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD6.699; A00ZJ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ5.699; A00ZK4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK4.699; A00ZX4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX4.699; A010AA.699 0100867770000209 13180921 17200921 1002-18-0036 21A010AA.699; A00ZL7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL7.699; A00ZL8.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL8.699; A0102T.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102T.699 A010A8.699 0100867770000209 13180921 17200921 1002-18-0036 21A010A8.699; A010TD.699 0100867770000209 13180921 17200921 1002-18-0036 21A010TD.699; A00ZY5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY5.699; A010QP.699 0100867770000209 13180921 17200921 1002-18-0036 21A010QP.699; A010T9.699 0100867770000209 13180921 17200921 1002-18-0036 21A010T9.699; A010UC.699 0100867770000209 13180921 17200921 1002-18-0036 21A010UC.699; A00ZL4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL4.699; A00ZN4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN4.699; A00ZP5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZP5.699; A00ZQ4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ4.699; A00ZW9.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW9.699; A00ZY1.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY1.699; A00ZY4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY4.699; A00ZY6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY6.699; A00ZZ7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZZ7.699; A010N1.699 0100867770000209 13180921 17200921 1002-18-0036 21A010N1.699; A00ZC7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC7.699; A00ZG3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZG3.699; A00ZX7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX7.699; A010PH.699 0100867770000209 13180921 17200921 1002-18-0036 21A010PH.699; A00ZC2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC2.699; A00ZC6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC6.699; A00ZH4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZH4.699
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