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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall CAPNOSTREAM 20P (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-0041-2019
Recall Event ID 80895
Product Classification Oximeter - Product Code DQA
Product CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
Code Information B638137550 B638137552 B638137553 B638137554 B638137556 B638137559 B638137562 B638137567 B638137568 B638137569 B638137572 B638137573 B638137574 B638137575 B638137576 B638137578 B638137581 B638137584 B638137587 B638137589 B638137594 B638137597 B638137598 B642138045 B642138050 B642138053 B642138054 B642138057 B642138061 B642138064 B642138073 B642138076 B642138077 B642138079 B642138080 B642138081 B642138085 B642138094 B642138097 B642138099 B642138107 B642138108 B642138109 B638137571 B616149193 B616149199 B616149200 B616149204 B616149209 B616149213 B616149216 B616149217 B616149218 B616149233 B625140084 B625140085 B625140087 B625140088 B625140089 B625140090 B625140092 B625140093 B625140094 B625140096 B625140098 B625140101 B625149944 B625149945 B625149946 B625149947 B625149948 B625149950 B625149951 B625149952 B625149953 B625149955 B625149956 B625149957 B625149958 B625149959 B625149960 B625149961 B625149962 B625149963 B625149964 B625149965 B625149966 B625149967 B625149970 B625149971 B625149972 B625149973 B625149974 B625149975 B625149977 B625149978 B625149979 B625149981 B625149982 B625149983 B625149984 B625149985 B625149986 B625149988 B625149989 B625149990 B625149991 B625149992 B625149994 B625149996 B625149997 B625149999 B625149976 
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 113
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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