Class 2 Device Recall CAPNOSTREAM 20 (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-0024-2019
• Recall Event ID: 80895
• 510(K)Number: K082268
• Product Classification: Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
• Product: CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
• Code Information: B20001115 B20001127 B200001151 B200001164 B200001206 B200001211 B200001254 B200001201 B200001180 B200001220 B200001236 B200001337 B200001179 B200001246 B200001261 B200001268 B200001293 B200001207 B200001242 B200001215 B200001217 B200001219 B200001247 B200001262 B200001380 B200001213 B200001421 B200001433 B200001442 B200001457 B200001464 B200001523 B200001465 B200001216 B200001455 B200001529 B200001619 B200001621 B200001623 B200001629 B200001649 B200001662 B200001676 B200001504 B200001390 B200001393 B200001575 B200001724 B200001941 B200001988 B200002012 B200002043 B200002084 B200002086 B200002118 B200002193 B400001903 B400002063 B400002083 B400002123 B400002177 B400002212 B400002216 B400002239 B200001804 B200002124 B200002052 B400002241 B400002246 B400002247 B400002254 B400002256 B400002228 B400002245 B400002251 B400002252 B200002127 B200002140 B200002152 B200002155 B200002157 B200001777 B400002026 B400002174 B400002191 B200001959 B200002011 B200002039 B200002044 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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: 1798
• 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 CAPNOGRAPHY, INC.