Class 2 Device Recall CAPNOSTREAM 20P (US) N W/PRINTER ROHS

• Date Initiated by Firm: July 31, 2018
• Create Date: October 03, 2018
• Recall Status: Terminated on September 20, 2022
• Recall Number: Z-0025-2019
• Recall Event ID: 80895
• 510(K)Number: K112368
• Product Classification: Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
• Product: CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
• Code Information: B819140007 B819140026 B819140032 B819140038 B819140050 B819140051 B819140052 B819140054 B819140060 B819140063 B820140069 B839141801 B839141803 B840141814 B840141819 B840141820 B840141823 B840141826 B839141802 B839141805 B839141807 B839141808 B839141809 B839141811 B839141812 B839141813 B840141815 B840141816 B840141818 B840141821 B840141822 B840141824 B840141827 B840141828 B840141829 B840141830 B840141831 B840141832 B840141833 B840141834 B840141835 B840141837 B840141838 B840141839 B840141843 B840141844 B840141847 B840141848 B840141849 B840141850 B819140004 B819140006 B819140008 B819140011 B819140012 B819140017 B819140020 B819140021 B819140031 B819140033 B819140037 B819140043 B819140045 B819140048 B819140034 B841142048 B844142441 B844142455 B845142604 B847142950 B848143034 B848143039 B848143043 B848143053 B848143084 B848143096 B848143104 B849143117 B849143118 B849143120 B849143121 B849143122 B849143123 B849143124 B849143130 B849143168 B849143233 B849143252 B849143253 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• Recalling Firm/ Manufacturer: Oridion Medical 1987 Ltd.; Har Hotzvim Industrial Park Box 45025; Har Hotzvim Industrial Park; Jerusalem Israel
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Urgent Medical Device Correction notification letters dated 7/31/18 were distributed to customers. The letters included the following instructions for customers: Share this notification with all care environments where the Capnostream" 20 and Capnostream" 20p bedside patient monitors are used, particularly in the areas where nurse call may be enabled (general care floors). If your facility has distributed these bedside patient monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. Medtronic is recommending continued use of Capnostream" devices. Users should confirm that the date/time is accurately displayed. If the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. Please follow the instruction in the Operators Manual to set user-defined default settings. The Operators Manual is available at http://www.medtronic.com/covidien/enus/support/product-manuals.html, refer to the Institutional Settings section. Return the completed Acknowledgement and Receipt Form by fax or email even if you have no inventory. In October 2018, download the software update from the Medtronic website via the following link which includes directions on how to download and install the software: http://www.medtronic.com/covidien/en-us/support/patient-monitoring-equipmentsoftware-upgrades.html.
• Quantity in Commerce: 2806
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CCK and Original Applicant = ORIDION MEDICAL 1987 LTD.