BEUDAMED
    FDA Enforcement Class II Terminated

    Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659

    Recall: Z-0035-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0035-2019
    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 (US) M W/PRINTER REFURBISHED, Part Number CS78659

    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

    B200001278 B300001166 B300001220 B300001070 B300001092 B300001097 B300001108 B300001172 B300001181 B300001185 B300001205 B300001278 B300001115 B500001885 B500001831 B300001015 B300001118 B500002336 B300001012 B300001132 B300001139 B500001819

    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

    22