BEUDAMED
    FDA Recall Terminated

    CapsoCAM Plus, UDI: 00867770000209

    Recall: Z-1827-2020 · Initiated October 18, 2019

    Recall

    Recall Number
    Z-1827-2020
    Event Number
    85378
    Firm
    Capso Vision, Inc.
    FEI Number
    3008062894
    Product Code
    NEZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 18, 2019
    Terminated
    January 8, 2021
    Address
    18805 Cox Ave, Ste 250, Saratoga, CA, 95070-6615

    Description

    CapsoCAM Plus, UDI: 00867770000209

    Reason

    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.

    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.

    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