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

• Date Initiated by Firm: July 31, 2018
• Create Date: October 03, 2018
• Recall Status: Terminated on September 20, 2022
• Recall Number: Z-0026-2019
• 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, Part Number CS08657-01
• Code Information: B400002777 B400002778 B400002779 B400002780 B400002781 B400002782 B400002783 B400002784 B400002785 B400002786 B600002902 B600002903 B600002905 B600002906 B600002908 B600002901 B600002904 B600002907 B632123517 B633123526 B621135542 B621135543 B621135544 B621135545 B621135546 B621135547 B621135548 B621135549 B621135550 B621135551 B621135552 B621135553 B621135554 B621135555 B621135556 B621135557 B621135558 B621135559 B621135560 B621135561 B621135562 B621135564 B621135566 B621135568 B621135569 B621135570 B621135571 B621135572 B621135573 B621135574 B621135575 B621135577 B621135578 B621135580 B621135582 B621135583 B621135584 B621135585 B621135586 B621135587 B621135589 B621135590 B621135591 B621135592 B621135594 B621135595 B621135588 B621135593 B633137055 B633137058 B633137060 B633137061 B633137062 B633137063 B633137064 B633137065 B633137066 B633137068 B633137069 B634137070 B634137071 B634137072 B634137073 B634137074 B634137075 B634137076 B634137077 B634137078 B634137079 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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: 1038
• 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.