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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall CAPNOSTREAM 20P (INTL) N W/PRINTER ROHS 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-0043-2019
Recall Event ID 80895
Product Classification Oximeter - Product Code DQA
Product CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
Code Information PA14170895 PA14170897 PA14170903 PA14170930 PA14170937 PA14170944 PA14170952 PA14170954 PA14170956 PA14170961 PA14170962 PA14170963 PA14170964 PA14170965 PA14170966 PA14170967 PA14170968 PA14170969 PA14170970 PA14170971 PA14170973 PA14170974 PA14170975 PA14170976 PA14170977 PA14170978 PA14170979 PA14170980 PA14170981 PA14170982 PA14170983 PA14170984 PA14170985 PA14170986 PA14170987 PA14170988 PA14170989 PA14170990 PA14170991 PA14170992 PA14170993 PA14170994 PA14170995 PA14170996 PA14170997 PA14170998 PA14170999 PA14171000 PA15171001 PA15171002 PA15171003 PA15171004 PA15171005 PA15171006 PA15171007 PA15171008 PA15171009 PA15171010 PA15171011 PA15171012 PA15171013 PA15171014 PA15171015 PA15171016 PA15171017 PA15171018 PA15171019 PA15171020 PA15171021 PA15171022 PA15171023 PA15171024 PA15171025 PA15171026 PA15171027 PA15171028 PA15171029 PA15171030 PA15171031 PA15171032 PA15171033 PA15171034 PA15171035 PA15171036 PA15171037 PA15171038 PA15171039 PA15171040 PA15171041 PA15171042 PA15171043 PA15171044 PA15171045 PA15171046 PA15171047 PA15171048 PA22172187 PA23172256 PA23172257 PA23172258 PA23172259 PA23172260 PA23172261 PA23172262 PA23172263 PA23172264 PA23172265 PA23172266 PA23172267 PA23172268 PA23172269 PA23172270 PA23172271 PA23172272 PA23172273 PA23172274 PA23172275 PA23172276 PA23172277 PA23172278 PA23172279 PA23172280 PA23172281 PA23172282 PA23172283 PA23172284 PA23172285 PA23172286 PA23172287 PA23172288 PA23172289 PA23172290 PA23172291 PA23172292 PA23172294 PA23172295 PA23172296 PA23172297 PA23172298 PA23172299 PA23172301 PA23172398 PA23172399 PA23172400 PA24172401 PA24172402 PA24172404 PA24172405 PA24172406 PA24172407 PA24172409 PA24172410 PA24172412 PA24172414 PA24172416 PA24172417 PA24172418 PA24172419 PA24172420 PA24172421 PA24172422 PA24172423 PA24172424 PA24172425 PA24172426 PA24172427 PA24172428 PA24172429 PA24172430 PA24172431 PA24172432 PA24172433 PA24172435 PA24172436 PA24172437 PA24172438 PA24172439 PA24172440 PA24172443 PA24172444 PA24172445 PA24172446 PA24172447 PA24172448 PA24172449 PA24172450 PA24172451 PA24172452 PA24172453 PA24172454 PA24172455 PA24172472 
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 192
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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