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U.S. Department of Health and Human Services

Class 2 Device Recall CAPNOSTREAM 20P (INTL) N

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 Class 2 Device Recall CAPNOSTREAM 20P (INTL) Nsee related information
Date Initiated by FirmJuly 31, 2018
Create DateOctober 03, 2018
Recall Status1 Terminated 3 on September 20, 2022
Recall NumberZ-0037-2019
Recall Event ID 80895
Product Classification Oximeter - Product Code DQA
ProductCAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
Code Information B642138114 B642138116 B642138122 B643138126 B643138128 B643138132 B643138134 B643138139 B643138144 B643138146 B643138150 B643138153 B643138156 B643138160 B643138166 B643138167 B643138168 B643138169 B643138170 B643138171 B643138172 B643138175 B643138177 B643138179 B643138181 B643138182 B643138190 B643138192 B643138215 B643138216 B643138217 B643138218 B643138219 B643138222 B643138224 B643138225 B643138228 B643138230 B643138232 B643138233 B643138240 B643138241 B643138243 B643138245 B643138253 B644138256 B644138259 B644138286 B644138287 B644138291 B610148829 B610148834 B610148838 B610148845 B611148924 B611148945 B611148946 B611148951 B612149038 B612149039 B615149045 B615149050 B615149054 B615149060 B615149062 B615149063 B615149070 B615149071 B615149073 B615149074 B615149086 B615149088 B615149090 B621149514 B622149593 B622149651 B622149654 B622149655 B622149658 B622149660 B622149663 B622149664 B622149665 B622149666 B622149668 B622149669 B622149670 B622149673 B622149674 B622149675 B622149680 B622149696 B622149701 B622149683 B622149685 B622149695 B622149697 B623149711 B623149712 B623149715 B623149716 B623149719 B624149862 B624149863 B624149866 B624149867 B624149876 B624149877 B624149880 B624149883 B624149887 B624149900 B643138174 
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 2		Nonconforming Material/Component
ActionUrgent 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 Commerce113
DistributionThe 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 CycleTPLC 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.
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