Class 2 Device Recall CAPNOSTREAM 20P (INTL) N ROHS

• Date Initiated by Firm: July 31, 2018
• Create Date: October 03, 2018
• Recall Status: Terminated on September 20, 2022
• Recall Number: Z-0038-2019
• Recall Event ID: 80895
• Product Classification: Oximeter - Product Code DQA
• Product: CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
• Code Information: B836141168 B836141196 B836141198 B836141206 B836141207 B836141209 B836141210 B836141212 B836141214 B836141217 B836141218 B836141221 B836141222 B836141223 B836141225 B836141226 B836141229 B836141230 B837141231 B837141232 B839141793 B840141875 B839141678 B839141682 B839141712 B841142027 B841142029 B841142033 B843142241 B844142389 B844142406 B844142411 B844142423 B844142426 B844142443 B844142449 B847142891 B847142906 B847142923 B847142938 B847142945 B847142947 B848142952 B848142970 B848142994 B848143001 B848143002 B801153800 B803153963 B803153964 B803153965 B803153968 B803153970 B803153971 B803153974 B803153975 B803153979 B803153981 B803153982 B803153983 B803153984 B803153985 B803153990 B841142053 B841142067 B851143673 B852143682 B850143423 B850143424 B850143425 B850143449 B850143450 B852143708 B852143715 B852143719 B852143736 B852143738 B852143743 B852143747 B852143750 B852143751 B852143755 B852143756 B852143757 B852143758 B852143760 B852143761 B852143762 B852143763 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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: 474
• 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.