Capso Vision, Inc. recalls The CapsoCam Plus (SV-3); Device Common Name: System, Imagin
Recalled 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.
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot number 01-19-0070 with the following S/N and associated UDIs: S/N A00Y2K.700, UDI 010086777000020913200204172107011001-19-007021A00Y2K.700; S/N A00Z9J.700, UDI 010086777000020913200204172107011001-19-007021A00Z9J.700; S/N A011EP.700, UDI 010086777000020913200204172107011001-19-007021A011EP.700; S/N A011F3.700, UDI 010086777000020913200204172107011001-19-007021A011F3.700; S/N A013BM.700, UDI 010086777000020913200204172107011001-19-007021A013BM.700; S/N A013D8.700, UDI 010086777000020913200204172107011001-19-007021A013D8.700; S/N A013EH.700, UDI 010086777000020913200204172107011001-19-007021A013EH.700; S/N A013F9.700, UDI 010086777000020913200204172107011001-19-007021A013F9.700; S/N A013FP.700, UDI 010086777000020913200204172107011001-19-007021A013FP.700; S/N A014ZB.700, UDI 010086777000020913200204172107011001-19-007021A014ZB.700; S/N A01535.700, UDI 010086777000020913200204172107011001-19-007021A01535.700; S/N A01536.700, UDI 010086777000020913200204172107011001-19-007021A01536.700; S/N A015AJ.700, UDI 010086777000020913200204172107011001-19-007021A015AJ.700; S/N A015DD.700, UDI 010086777000020913200204172107011001-19-007021A015DD.700; S/N A015FB.700, UDI 010086777000020913200204172107011001-19-007021A015FB.700; S/N A015MK.700, UDI 010086777000020913200204172107011001-19-007021A015MK.700; S/N A015S1.700, UDI 010086777000020913200204172107011001-19-007021A015S1.700; S/N A015S2.700, UDI 010086777000020913200204172107011001-19-007021A015S2.700; S/N A015S9.700, UDI 010086777000020913200204172107011001-19-007021A015S9.700; S/N A015T3.700, UDI 010086777000020913200204172107011001-19-007021A015T3.700; S/N A015V7.700, UDI 010086777000020913200204172107011001-19-007021A015V7.700; S/N A015WH.700, UDI 010086777000020913200204172107011001-19-007021A015WH.700; S/N A015YC.700, UDI 010086777000020913200204172107011001-19-007021A015YC.700; S/N A01605.700, UDI 010086777000020913200204172107011001-19-007021A01605.700; S/N A016B1.700, UDI 010086777000020913200204172107011001-19-007021A016B1.700; S/N A016EN.700, UDI 010086777000020913200204172107011001-19-007021A016EN.700; S/N A016G4.700, UDI 010086777000020913200204172107011001-19-007021A016G4.700; S/N A016G7.700, UDI 010086777000020913200204172107011001-19-007021A016G7.700; S/N A016JB.700, UDI 010086777000020913200204172107011001-19-007021A016JB.700; S/N A01878.700, UDI 010086777000020913200204172107011001-19-007021A01878.700; S/N A01880.700, UDI 010086777000020913200204172107011001-19-007021A01880.700; S/N A0188Z.700, UDI 010086777000020913200204172107011001-19-007021A0188Z.700; S/N A0189M.700, UDI 010086777000020913200204172107011001-19-007021A0189M.700; S/N A018BZ.700, UDI 010086777000020913200204172107011001-19-007021A018BZ.700; S/N A018D2.700, UDI 010086777000020913200204172107011001-19-007021A018D2.700; S/N A018DY.700, UDI 010086777000020913200204172107011001-19-007021A018DY.700; S/N A018T7.700, UDI 010086777000020913200204172107011001-19-007021A018T7.700; S/N A018TA.700, UDI 010086777000020913200204172107011001-19-007021A018TA.700; S/N A018TD.700, UDI 010086777000020913200204172107011001-19-007021A018TD.700; S/N A018TF.700, UDI 010086777000020913200204172107011001-19-007021A018TF.700; S/N A018TN.700, UDI 010086777000020913200204172107011001-19-007021A018TN.700; S/N A018UC.700, UDI 010086777000020913200204172107011001-19-007021A018UC.700; S/N A018UL.700, UDI 010086777000020913200204172107011001-19-007021A018UL.700; S/N A018VF.700, UDI 010086777000020913200204172107011001-19-007021A018VF.700; S/N A018VG.700, UDI 010086777000020913200204172107011001-19-007021A018VG.700; S/N A018X5.700, UDI 010086777000020913200204172107011001-19-007021A018X5.700; S/N A018XP.700, UDI 010086777000020913200204172107011001-19-007021A018XP.700; S/N A018YR.700, UDI 010086777000020913200204172107011001-19-007021A018YR.700; S/N A01901.700, UDI 010086777000020913200204172107011001-19-007021A01901.700; S/N A0190B.700, UDI 010086777000020913200204172107011001-19-007021A0190B.700; S/N A0191F.700, UDI 010086777000020913200204172107011001-19-007021A0191F.700; S/N A0191L.700, UDI 010086777000020913200204172107011001-19-007021A0191L.700; S/N A0192C.700, UDI 010086777000020913200204172107011001-19-007021A0192C.700; S/N A0192G.700, UDI 010086777000020913200204172107011001-19-007021A0192G.700; S/N A0192J.700, UDI 010086777000020913200204172107011001-19-007021A0192J.700; S/N A0192X.700, UDI 010086777000020913200204172107011001-19-007021A0192X.700; S/N A0192Y.700, UDI 010086777000020913200204172107011001-19-007021A0192Y.700; S/N A01936.700, UDI 010086777000020913200204172107011001-19-007021A01936.700; S/N A0193A.700, UDI 010086777000020913200204172107011001-19-007021A0193A.700; S/N A0193S.700, UDI 010086777000020913200204172107011001-19-007021A0193S.700; S/N A0194A.700, UDI 010086777000020913200204172107011001-19-007021A0194A.700; S/N A0194D.700, UDI 010086777000020913200204172107011001-19-007021A0194D.700; S/N A0194K.700, UDI 010086777000020913200204172107011001-19-007021A0194K.700; S/N A0194P.700, UDI 010086777000020913200204172107011001-19-007021A0194P.700; S/N A0194X.700, UDI 010086777000020913200204172107011001-19-007021A0194X.700; S/N A01950.700, UDI 010086777000020913200204172107011001-19-007021A01950.700; S/N A0195S.700, UDI 010086777000020913200204172107011001-19-007021A0195S.700; S/N A0195Y.700, UDI 010086777000020913200204172107011001-19-007021A0195Y.700; S/N A01968.700, UDI 010086777000020913200204172107011001-19-007021A01968.700; S/N A0196W.700, UDI 010086777000020913200204172107011001-19-007021A0196W.700; S/N A0196Y.700, UDI 010086777000020913200204172107011001-19-007021A0196Y.700; S/N A0196Z.700, UDI 010086777000020913200204172107011001-19-007021A0196Z.700; S/N A01970.700, UDI 010086777000020913200204172107011001-19-007021A01970.700; S/N A0197C.700, UDI 010086777000020913200204172107011001-19-007021A0197C.700; S/N A0197W.700, UDI 010086777000020913200204172107011001-19-007021A0197W.700; S/N A01986.700, UDI 010086777000020913200204172107011001-19-007021A01986.700; S/N A0198Z.700, UDI 010086777000020913200204172107011001-19-007021A0198Z.700; S/N A01994.700, UDI 010086777000020913200204172107011001-19-007021A01994.700; S/N A0199V.700, UDI 010086777000020913200204172107011001-19-007021A0199V.700; S/N A0199Y.700, UDI 010086777000020913200204172107011001-19-007021A0199Y.700; S/N A019A1.700, UDI 010086777000020913200204172107011001-19-007021A019A1.700; S/N A019AN.700, UDI 010086777000020913200204172107011001-19-007021A019AN.700.
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