CapsoCAM Plus, UDI: 00867770000209
Check against the official notice below — it lists the full affected range.
Capso Vision, Inc. has recalled 1,882 units of the CapsoCAM Plus Capsule Endoscopy System due to a defect in the capsule window. The defect may be stressed during production and packaging, potentially causing the capsule housing to crack and leak when ingested. If this occurs, patient fluid could leak into the capsule and damage internal components, preventing patient data from being retrieved and potentially requiring the patient to undergo a repeat examination.
The recalled devices were distributed throughout the United States in California, Texas, Florida, Virginia, Pennsylvania, South Carolina, Hawaii, Washington D.C., New Jersey, Utah, and Louisiana, as well as internationally in France, Argentina, Italy, the United Kingdom, Belgium, the Turks and Caicos Islands, Australia, Colombia, Germany, Greece, Spain, Slovenia, Croatia, Morocco, Sweden, and Equatorial Guinea. The specific serial numbers of affected units are listed in the recall record. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA. Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ. Quantity: 1882 Lot/code info: Serial Numbers: A017NP.699 A0168D.699 A016RR.699 A016W3.699 A016SA.699 A0175B.699 A016SY.699 A017AY.699 A016T0.699 A017D6.699 A016U9.699 A017NF.699 A016VC.699 A017Q0.699 A016XA.699 A017Q3.699 A016YB.699 A0189A.699 A016Z5.699 A018BB.699 A0171D.699 A018C5.699 A0171W.699 A018FY.699 A0172S.699 A018JF.699 A0173D.699 A0195K.699 A01749.699 A016FA.699 A0174N.699 A017GD.699 A0175J.699 A0180X.699 A0176P.699 A0182Z.699 A01772.699 A0186Q.699 A0177Q.699 A0187Y.699 A0178D.699 A0189J.699 A0178F.699 A0189X.699 A0178G.699 A018FS.699 A0178S.699 A018J3.699 A0178W.699 A0192E.699 A01790.699 A016CV.699 A01794.699 A016D1.699 A01799.699 A016D4.699 A0179E.699 A016D6.699 A0179H.699 A016DA.699 A0179K.699 A016DB.699 A0179P.699 A016DF.699 A0179Q.699 A016DH.699 A0179R.699 A016DP.699 A0179S.699 A016DQ.699 A0179W.699 A016ET.699 A0179Y.699 A016EV.699 A017AH.699 A016F3.699 A017AP.699 A016F8.699 A017AS.699 A016FN.699 A017B8.699 A016FR.699 A017BH.699 A016FX.699 A017BJ.699 A016FY.699 A017BK.699 A016FZ.699 A017BP.699 A016G3.699 A017BS.699 A016G9.699 A017BU.699 A016GA.699 A017C7.699 A016GF.699 A017CD.699 A016GK.699 A017CE.699 A016GM.699 A017CN.699 A016GS.699 A017CP.699 A016H1.699 A017CX.699 A016HQ.699 A017D5.699 A016JE.699 A017DD.699 A016JP.699 A017DF.699 A016JX.699 A017DG.699 A016K1.699 A017DR.699 A016K3.699 A017E1.699 A016K7.699 A017EC.699 A016KK.699 A017EF.699 A016KX.699 A017EH.699 A016L6.699 A017EK.699 A016L9.699 A017ER.699 A016LF.699 A017EV.699 A016LJ.699 A017EY.699 A016LU.699 A017F5.699 A016LX.699 A017F6.699
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.