Class 2 Device Recall CapsoCam Plus video capsule system

• Date Initiated by Firm: October 18, 2019
• Create Date: April 30, 2020
• Recall Status: Terminated on January 08, 2021
• Recall Number: Z-1827-2020
• Recall Event ID: 85378
• 510(K)Number: K183192
• Product Classification: System, imaging, gastrointestinal, wireless, capsule - Product Code NEZ
• Product: CapsoCAM Plus, UDI: 00867770000209
• Code Information: 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 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• Recalling Firm/ Manufacturer: Capso Vision, Inc.; 18805 Cox Ave Ste 250; Saratoga CA 95070-6615
• For Additional Information Contact: 408-866-6358
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: Starting on 10/18/19, Urgent Medical Device Voluntary Recall Letters were emailed to customers. Customers were asked return affected product and to complete the Return Material Authorization form. The recalling firm asked distributors to provide their latest shipment lists.
• Quantity in Commerce: 1882
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NEZ