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The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsul...

FDA Device Recall #Z-2536-2020 — Class II — February 26, 2020

Recall Summary

Recall Number Z-2536-2020
Classification Class II — Moderate risk
Date Initiated February 26, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Capso Vision, Inc.
Location Saratoga, CA
Product Type Devices
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.

Lot / 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.

Other Recalls from Capso Vision, Inc.

Recall # Classification Product Date
Z-1827-2020 Class II CapsoCAM Plus, UDI: 00867770000209 Oct 18, 2019
Z-2073-2020 Class II CapsoCam Plus *** System, Imaging, Gastrointest... Jul 3, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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