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-0027-2019
• 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 CS08657-03
• Code Information: PA10170221 PA10170222 PA10170224 PA10170226 PA10170227 PA10170238 PA10170240 PA48160004 PA48160009 PA48160011 PA48160012 PA50160014 PA50160017 PA50160021 PA50160023 PA50160024 PA50160025 PA50160026 PA50160027 PA50160028 PA50160029 PA50160030 PA51160034 PA51160035 PA51160036 PA51160037 PA51160038 PA51160039 PA51160040 PA51160041 PA51160042 PA51160043 PA51160044 PA51160045 PA51160046 PA51160047 PA51160048 PA51160049 PA51160050 PA51160051 PA51160053 PA51160054 PA51160055 PA51160056 PA51160057 PA51160058 PA51160059 PA51160060 PA14170880 PA14170881 PA14170882 PA14170883 PA14170884 PA14170885 PA14170886 PA14170887 PA14170888 PA14170889 PA14170890 PA14170891 PA14170892 PA14170893 PA14170894 PA14170896 PA14170898 PA14170899 PA14170900 PA14170901 PA14170902 PA14170904 PA14170905 PA14170906 PA14170907 PA14170908 PA14170909 PA14170910 PA14170911 PA14170912 PA14170913 PA14170914 PA14170915 PA14170916 PA14170917 PA14170918 PA14170919 PA14170920 PA14170921 PA14170922 PA14170923 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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: 696
• 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