Reported May 6, 2020 · Terminated
CapsoCAM Plus, UDI: 00867770000209
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?
- CapsoCAM Plus
- UDI00867770000209
- Lot codes and dates
- Serial Numbers
1,882 of 1,882 codes
A017NP.699A0168D.699A016RR.699A016W3.699A016SA.699A0175B.699A016SY.699A017AY.699A016T0.699A017D6.699A016U9.699A017NF.699A016VC.699A017Q0.699A016XA.699A017Q3.699A016YB.699A0189A.699A016Z5.699A018BB.699A0171D.699A018C5.699A0171W.699A018FY.699A0172S.699A018JF.699A0173D.699A0195K.699A01749.699A016FA.699A0174N.699A017GD.699A0175J.699A0180X.699A0176P.699A0182Z.699A01772.699A0186Q.699A0177Q.699A0187Y.699A0178D.699A0189J.699A0178F.699A0189X.699A0178G.699A018FS.699A0178S.699A018J3.699A0178W.699A0192E.699A01790.699A016CV.699A01794.699A016D1.699A01799.699A016D4.699A0179E.699A016D6.699A0179H.699A016DA.699
- UDI00867770000209
- Serial Numbers
- Amount recalled
- 1882
Where it was sold
Why it was recalled
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
This product could cause temporary or reversible health problems — stop using it.
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