Home / Recalls / Capso Vision, Inc. / Z-2536-2020

Z-2536-2020 Class II Terminated

Recalled by Capso Vision, Inc. — Saratoga, CA

FDA device recall Z-2536-2020 was initiated by Capso Vision, Inc. on February 26, 2020 and is designated Class II. Reason for recall: 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 pati… The recall status is terminated (terminated January 28, 2021). Affected quantity: 82.

Recall Details

Product Type: Devices
Report Date: July 15, 2020
Initiation Date: February 26, 2020
Termination Date: January 28, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 82

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.

Code Information

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.