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-0039-2019
• Recall Event ID: 80895
• Product Classification: Oximeter - Product Code DQA
• Product: CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
• Code Information: PA12170508 PA12170656 PA12170657 PA12170702 PA13170746 PA13170769 PA13170777 PA13170782 PA13170783 PA13170786 PA13170787 PA13170798 PA14170801 PA14170802 PA14170803 PA14170807 PA14170808 PA14170811 PA14170812 PA14170813 PA14170814 PA14170815 PA14170816 PA14170817 PA14170818 PA14170819 PA14170820 PA14170821 PA14170822 PA14170823 PA14170824 PA14170825 PA14170826 PA14170827 PA14170828 PA14170829 PA14170830 PA14170831 PA14170832 PA14170833 PA14170834 PA14170835 PA14170836 PA14170837 PA14170838 PA14170839 PA14170840 PA14170841 PA14170842 PA14170843 PA14170844 PA14170845 PA14170846 PA14170847 PA14170848 PA14170849 PA14170850 PA14170851 PA14170852 PA14170853 PA14170854 PA14170855 PA14170856 PA14170857 PA14170858 PA14170859 PA14170860 PA14170861 PA14170862 PA14170863 PA14170864 PA14170865 PA14170866 PA14170867 PA14170868 PA14170869 PA14170870 PA14170871 PA14170872 PA14170873 PA14170874 PA14170875 PA14170876 PA14170877 PA14170878 PA14170879 PA15171049 PA15171050 PA15171051 PA15171053 PA15171054 PA15171055 PA15171056 PA15171057 PA15171058 PA15171059 PA22172143 PA23172302 PA23172307 PA23172308 PA23172310 PA23172311 PA23172312 PA23172313 PA23172314 PA23172315 PA23172316 PA23172317 PA23172318 PA23172319 PA23172320 PA23172321 PA23172322 PA23172323 PA23172324 PA23172325 PA23172326 PA23172327 PA23172328 PA23172330 PA23172331 PA23172332 PA23172333 PA23172334 PA23172335 PA23172336 PA23172337 PA23172338 PA23172341 PA23172342 PA23172343 PA23172344 PA23172346 PA23172347 PA23172348 PA23172349 PA23172350 PA23172351 PA23172352 PA23172353 PA23172354 PA23172355 PA23172356 PA23172357 PA23172358 PA23172359 PA23172360 PA23172361 PA23172362 PA23172363 PA23172364 PA23172365 PA23172366 PA23172367 PA23172368 PA23172369 PA23172370 PA23172372 PA23172373 PA23172374 PA23172375 PA23172376 PA23172377 PA23172378 PA23172379 PA23172380 PA23172381 PA23172382 PA23172383 PA23172384 PA23172385 PA23172386 PA23172388 PA23172389 PA23172390 PA23172391 PA23172392 PA23172393 PA23172394 PA23172395 PA23172396 PA23172397 PA24172434 PA24172490 PA24172491 PA24172492 PA24172494 PA24172495 PA24172496 PA24172497 PA24172498 PA24172501 PA36173719 PA36173739 PA36173749 PA36173766 PA36173768 PA36173769 PA36173770 PA36173772 PA36173774 PA36173777 PA36173779 PA36173781 PA36173782 PA36173783 PA36173784 PA36173785 PA36173786 PA36173787 PA36173788 PA36173789 PA36173791 PA36173792 PA36173793 PA36173794 PA37173871 PA37173872 PA37173873 PA37173874 PA38173875 PA38173876 PA38173877 PA38173878 PA38173879 PA38173880 PA38173881 PA38173882 PA38173883 PA38173884 PA38173885 PA38173886 PA38173887 PA38173888 PA38173889 PA38173890 PA38173891 PA38173892 PA38173893 PA38173894 PA41174126 PA41174127 PA41174128 PA41174129 PA41174130 PA42174131 PA42174132 PA42174133 PA42174134 PA42174135 PA42174136 PA42174137 PA42174138 PA42174139 PA42174140 PA43174141 PA43174142 PA43174143 PA43174144 PA43174145 PA43174146 PA43174147 PA43174148 PA43174149
• 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: 264
• 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.