BEUDAMED
    FDA Enforcement Class II Terminated

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    Recall: Z-0045-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0045-2019
    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 M ADULT ICU (CPM), CS08654RA

    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

    B3000011359 B300001366 B300001445 B300001452 B300001460

    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

    5