BEUDAMED
    FDA Enforcement Class II Terminated

    Capnostream20 (US)M REFURBISHED, Part Number CS78653

    Recall: Z-0033-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0033-2019
    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 REFURBISHED, Part Number CS78653

    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

    B300001025 B300001053 B300001106 B300001109 B300001140 B300001178 B300001219 B300001282 B300001304 B300001324 B300001262 B300001094 B300001177 B300001208 B300001242 B300001246 B300001313 B500002196 B300001188 B300001236 B300002173 B500002408 B300001071 B300001075 B300001124 B300001204 B300001248 B300001443 B500001655 B500001659 B500001660 B500001666 B500001670 B500001683 B500001701 B500001806 B500001817 B500002130 B500002189 B500002231 B300001066 B300001244 B300001207

    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

    43