Capso Vision, Inc.: 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.

Recall number

Z-2536-2020

Recalling firm

Capso Vision, Inc.

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.

Status

Terminated

Initiated

2020-02-26

Posted

not on file

Terminated

2021-01-28

Reason

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.

Root cause

Employee error

Action

Beginning 02/26/2020, the firm notified affected customers via email of "URGENT: Medical Device Voluntary Recall Letter". The letter indicated, as soon as the customer receives the notice, please provide acknowledgment of receipt. The letter requested actions to be taken by the customer/user: We request that you ship back the affected capsules using the provided RMA form and return shipping label. For any concerns or question email or contact the firm at (408) 866-6358.

Quantity

82

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

["K192662"]

PMA numbers

not on file

Product code

NEZ

Firm FEI

3008062894

Firm city

Saratoga

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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