BEUDAMED
    FDA Enforcement Class II Terminated

    Capnostream20 N CYVITAL, CS08799

    Recall: Z-0050-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0050-2019
    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 N CYVITAL, CS08799

    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

    B400002614 B400002628 B400002640 B400002642 B400002645 B400002646 B400002653 B400002658 B400002659 B400002660 B400002750 B400002760 B417135110 B417135186 B417135189 B418135223 B418135272 B418135278 B419135324 B419135329

    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

    20