BEUDAMED
    FDA Enforcement Class II Terminated

    Capnostream20 (INTL) M, CS08654

    Recall: Z-0044-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0044-2019
    Event ID
    80895
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oridion Medical 1987 Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    July 31, 2018
    Classification Date
    October 3, 2018
    Termination Date
    September 20, 2022
    Address
    Har Hotzvim Industrial Park Box 45025, Har Hotzvim Industrial Park, Jerusalem, N/A, Israel

    Description

    Capnostream20 (INTL) M, CS08654

    Reason

    The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

    Code Info

    B300001030 B300001023 B300001019 B300001021 B300001022 B300001027 B300001037 B300001038 B300001039 B300001020 B300001034 B300001076 B300001449 B300001418 B300001430 B300001458 B300001466 B300001469 B500001545 B500001546 B500001552 B500001558 B500001578 B500001579 B500001591 B30001370 B300001310 B500001551 B500001589 B500001770 B500001761 B500001765 B500001962 B500001982 B500001949 B500001921 B500001922 B500001923 B500001940 B500001947 B500001972 B500001975 B500001993 B500001989 B500002043 B500002767 B500001820 B500002596 B500002601 B500002605 B500002606 B500002607 B500002735 B500002740 B500002743 B500002759

    Distribution

    The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.

    Quantity

    56