Class 2 Device Recall CAPNOSTREAM 20P (INTL) 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-0042-2019
• Recall Event ID: 80895
• Product Classification: Oximeter - Product Code DQA
• Product: CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
• Code Information: B819140013 B819140014 B819140015 B819140024 B819140030 B819140042 B819140044 B819140049 B820140072 B820140075 B820140077 B820140078 B820140079 B820140080 B820140081 B819140003 B819140005 B819140010 B819140016 B819140018 B819140023 B819140025 B819140028 B819140029 B819140035 B819140036 B819140039 B819140047 B819140056 B819140059 B819140062 B820140067 B820140068 B820140071 B820140073 B820140074 B820140082 B819140009 B819140022 B819140027 B819140040 B819140041 B819140046 B819140053 B819140055 B819140057 B819140058 B819140061 B819140064 B819140066 B820140070 B839141804 B839141806 B839141810 B840141817 B840141841 B840141842 B840141836 B840141840 B840141845 B840141846 B848143029 B850143387 B851143493 B851143500 B851143504 B851143505 B851143534 B851143541 B851143548 B851143550 B851143553 B851143556 B851143566 B851143569 B851143578 B802153887 B802153892 B802153936 B802153947 B803153953 B802153812 B802153817 B802153834 B802153859 B802153879 B802153891 B802153903 B802153914 B802153940 B802153942 B803154038 B803154050 B804154170 B804154182 B804154191 B804154193 B804154199 B804154216 B804154245 B805154263 B805154265 B805154267 B851143580 B851143609 B851143638 B811155297 B811155312 B811155316 B811155317 B811155318 B811155324 B811155328 B811155330 B811155331 B811155332 B811155333 B811155334 B811155336 B811155340 B811155343 B802153855 B803153962 B804154095 B804154214 B804154246 B805154258 B805154264 B805154266 B805154271 B811155306 B811155320 B840141825 B842142222 B847142844 B851143537 B852143749 B852143771 B806154519 B812155486 B812155581 B812155588 B812155590 B812155598 B812155600 B812155619 B812155691 B812155696 B812155698 B812155700 B812155709 B812155715 B812155716 B812155721 B812155724 B812155726 B812155728 B812155732 B812155733 B812155737 B841141969 B850143455 P835150001 P835150002 P835150003 P835150004 P835150005 P835150006 P835150007 P835150008 P835150009 P835150010 P835150011 P835150012 P835150013 P835150014 P835150015 P835150016 P835150017 P835150018 P835150019 P835150020 P835150021 P835150022 P835150023 P835150024 P842150385 P842150386 P842150387 P842150388 P844150389 P844150390 P844150391 P844150392 P844150393 P844150394 P844150395 P844150396 P844150397 P844150398 P844150399 P844150400 P844150401 P844150402 P844150403 P844150404 P844150405 P844150406 P844150407 P844150408 P844150409 P844150410 P844150411 P844150412 P844150413 P844150414 P844150415 P844150416 P844150417 P844150418 P844150419 P844150420 P844150421 P844150422 P844150423 P844150424 P844150425 P844150426 P844150427 P844150428 P844150429 P844150430 P844150431 P844150432 B819140065 B804154068 B805154363 B844142499 B849143206 P836162740 P837162788 P837162789 P837162790 P837162791 P837162792 P837162796 P837162797 P837162798 P837162799 P837162800 P837162801 P837162802 P837162803 P837162804 P837162805 P837162806 P837162808 P837162809 P837162810 P837162811 P837162813 P837162814 P837162815 P842163740 P842163759 P843163867 P843163914 P843163926 P843163927 P843163928 P843163930 P843163931 P843163932 P843163933 P843163934 P843163935 P843163936 P843163937 P843163938 P843163941 P843163942 P843163943 P843163945 P843163946 P843163947 P843163948 P843163950 P843163951 P843163953 P843163954 P843163955 P843163957 P843163958 P843163959 P843163960 P843163961 P843163962 P843163965 P843163966 P843163968 P843163972 P843163925 P843163949 P843163967 P845164257 P845164258 P845164260 P845164261 P845164262 P845164264 P845164265 P845164266 P845164267 P845164268 P845164270 P845164271 P845164272 P845164273 P845164274 P845164275 P845164276 P845164277 P845164279 P845164280 P846164281 P846164282 P846164283 P846164284 P846164285 P846164286 P846164287 P846164288 P846164387 P846164388 P846164389 P803176081 P803176082 P803176083 P803176084 P803176085 P803176086 P803176087 P803176088 P803176089 P803176090 P804176091 P804176092 P804176093 P804176094 P804176095 P804176096 P804176097 P804176098 P804176099 P804176100 P804176101 P804176102 P804176103 P804176104 P806176449 P806176450 P806176451 P806176452 P806176453 P806176454 P806176455 P806176456 P806176457 P806176458 P806176459 P806176460 P806176461 P806176462 P806176463 P806176464 P806176465 P806176466 P806176467 P806176468 P806176469 P806176470 P806176471 P806176472
• 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: 383
• 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.