Class 2 Device Recall CAPNOSTREAM 20P (US) N

• Date Initiated by Firm: July 31, 2018
• Create Date: October 03, 2018
• Recall Status: Terminated on September 20, 2022
• Recall Number: Z-0021-2019
• Recall Event ID: 80895
• 510(K)Number: K112368
• Product Classification: Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
• Product: CAPNOSTREAM 20P (US) N, Part Number CS08651-01
• Code Information: B632123514 B632123522 B633123527 B633123528 B646113021 B646113026 B646113035 B646113037 B646113040 B646113041 B632123520 B646113023 B646113028 B642138118 B642138121 B642138123 B642138125 B643138127 B643138129 B643138131 B643138133 B643138135 B643138137 B643138138 B643138142 B643138143 B643138145 B643138147 B643138148 B643138157 B643138158 B643138159 B643138161 B643138163 B643138164 B646113029 B642138124 B643138149 B643138178 B643138184 B643138185 B643138188 B643138189 B643138194 B643138196 B643138197 B643138199 B643138200 B643138202 B643138203 B643138204 B643138205 B643138206 B643138207 B643138210 B643138211 B643138213 B643138214 B643138227 B643138229 B643138231 B643138234 B643138236 B643138237 B643138248 B644138275 B644138276 B644138280 B644138283 B644138288 B644138289 B644138290 B644138294 B645138308 B645138313 B645138319 B645138328 B645138330 B645138333 B645138334 B645138338 B645138343 B645138347 B645138368 B643138173 B643138180 B643138212 B643138223 B643138235 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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: 1819
• 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.