BEUDAMED
    FDA Enforcement Class II Terminated

    Capnostream20 (INTL) M W/PRINTER, CS08660

    Recall: Z-0047-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0047-2019
    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 W/PRINTER, CS08660

    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

    B300001031 B300001047 B300001049 B300001052 B300001065 B300001453 B300001454 B300001468 B300001130 B300001325 B500001762 B500001843 B500001892 B500001915 B500001945 B500002146 B500002103 B500002150 B500002132 B502123108 B523123180 B523123182 B523123186

    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

    23