Reported Jul 15, 2020 · Terminated
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795…
Capso Vision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Capso Vision, Inc. · 18805 Cox Ave Ste 250 · Saratoga, CA · 95070-6615
Is this the product you have?
- The CapsoCam Plus (SV-3)
- Device Common NameSystem, Imaging, Gastrointestinal, Wireless, Capsule
- Catalog Number 2795 - Product Usageintended 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
- Lot codes and dates
82 of 82 products
Products covered by this recall # Product as published 1 S/N A00Y2K.700, UDI 010086777000020913200204172107011001-19-007021A00Y2K.700 2 S/N A00Z9J.700, UDI 010086777000020913200204172107011001-19-007021A00Z9J.700 3 S/N A011EP.700, UDI 010086777000020913200204172107011001-19-007021A011EP.700 4 S/N A011F3.700, UDI 010086777000020913200204172107011001-19-007021A011F3.700 5 S/N A013BM.700, UDI 010086777000020913200204172107011001-19-007021A013BM.700 6 S/N A013D8.700, UDI 010086777000020913200204172107011001-19-007021A013D8.700 7 S/N A013EH.700, UDI 010086777000020913200204172107011001-19-007021A013EH.700 8 S/N A013F9.700, UDI 010086777000020913200204172107011001-19-007021A013F9.700 9 S/N A013FP.700, UDI 010086777000020913200204172107011001-19-007021A013FP.700 10 S/N A014ZB.700, UDI 010086777000020913200204172107011001-19-007021A014ZB.700 11 S/N A01535.700, UDI 010086777000020913200204172107011001-19-007021A01535.700 12 S/N A01536.700, UDI 010086777000020913200204172107011001-19-007021A01536.700 13 S/N A015AJ.700, UDI 010086777000020913200204172107011001-19-007021A015AJ.700 14 S/N A015DD.700, UDI 010086777000020913200204172107011001-19-007021A015DD.700 15 S/N A015FB.700, UDI 010086777000020913200204172107011001-19-007021A015FB.700 16 S/N A015MK.700, UDI 010086777000020913200204172107011001-19-007021A015MK.700 17 S/N A015S1.700, UDI 010086777000020913200204172107011001-19-007021A015S1.700 18 S/N A015S2.700, UDI 010086777000020913200204172107011001-19-007021A015S2.700 19 S/N A015S9.700, UDI 010086777000020913200204172107011001-19-007021A015S9.700 20 S/N A015T3.700, UDI 010086777000020913200204172107011001-19-007021A015T3.700 - Amount recalled
- 82
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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