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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall CAPNOSTREAM 20 (INTL) N W/PRINTER see related information
Date Initiated by Firm July 31, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on September 20, 2022
Recall Number Z-0040-2019
Recall Event ID 80895
Product Classification Oximeter - Product Code DQA
Product CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
Code Information B200001028 B200001034 B200001060 B200001022 B200001023 B200001038 B200001041 B200001042 B200001052 B200001054 B200001055 B200001056 B200001024 B200001039 B200001040 B200001049 B200001051 B200001058 B200001059 B200001026 B200001029 B200001037 B200001031 B200001094 B200001033 B200001172 B200001228 B200001050 B200001459 B200001025 B400002243 B200001045 B200001047 B200001044 B200001138 B200001689 B200001832 B200001837 B200001854 B200001855 B200001645 B200001633 B200001917 B400002296 B400002401 B400002435 B400002444 B400002350 B400002453 B400002451 B400002454 B200001839 B200001573 B440112951 B440112966 B440112973 B417123382 B417123383 B417123387 B440112949 B417123381 B417123384 B417123386 B417123385 B410123238 B447123766 B447123768 B447123769 B448123792 B200002165 B411134508 B411134523 B411134459 B411134469 B440112945 B400002441 B416135016 B416135070 B400002237 B423135806 B423135807 B423135808 B423135811 B424135818 B424135821 B424135824 B424135828 B424135830 B424135832 B424135833 B424135835 B424135836 B424135839 B424135842 B424135843 B424135846 B424135848 B424135853 B424135856 B424135859 B424135861 B200001159 B428136417 B428136419 B428136423 B428136425 B428136427 B428136428 B428136431 B428136432 B428136438 B428136444 B428136445 B428136447 B428136455 B428136459 B428136462 B428136464 B428136466 B428136407 B428136408 B428136414 B428136418 B428136421 B428136422 B428136424 B428136426 B428136429 B428136434 B428136436 B428136441 B428136443 B428136446 B428136449 B428136450 B428136452 B428136456 B428136457 B428136458 B428136461 B428136463 B200001053 B407123203 B428136416 
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
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 144
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.
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