Class 2 Device Recall CAPNOSTREAM 20 (INTL) N

• Date Initiated by Firm: July 31, 2018
• Create Date: October 03, 2018
• Recall Status: Terminated on September 20, 2022
• Recall Number: Z-0036-2019
• Recall Event ID: 80895
• Product Classification: Oximeter - Product Code DQA
• Product: CAPNOSTREAM 20 (INTL) N, Part Number CS08652
• Code Information: B200001301 B200001306 B200001625 B200002065 B200002206 B200001982 B200002098 B200001475 B200002000 B200001865 B200001835 B200001944 B200002030 B200002202 B200001012 B200001314 B200001866 B200002032 B200002139 B200001723 B200001908 B200001926 B200001703 B200001755 B200001500 B200001763 B200001519 B200001653 B200001655 B200001661 B200001670 B200001722 B400001155 B400002342 B200001729 B400002520 B400002480 B400002505 B200001802 B400002492 B400002518 B400002521 B400002542 B400002728 B400002713 B400002800 B400002813 B451113083 B450113072 B406123152 B406123163 B408123213 B400002450 B410123265 B420123420 B420123421 B400002844 B440112971 B447123778 B449123886 B449123889 B449123899 B449123915 B449123917 B449123919 B449123920 B449123921 B449123922 B449123924 B449123925 B449123927 B449123930 B449123931 B449123936 B449123938 B449123939 B449123963 B449123967 B450123979 B450123982 B450123983 B450123985 B450123989 B450123991 B450123994 B450123995 B450123998 B450123999 B450124000 B450124001 B450124003 B451124006 B415123322 B420123441 B445123646 B448123832 B405134172 B405134174 B408134285 B408134293 B408134300 B409134335 B409134341 B409134366 B409134370 B409134372 B409134373 B409134374 B410134375 B410134376 B410134377 B410134378 B410134379 B410134380 B410134381 B410134383 B410134384 B410134385 B410134386 B410134388 B410134389 B410134390 B410134391 B410134392 B410134393 B410134395 B410134396 B410134397 B410134398 B410134399 B410134402 B410134403 B410134404 B410134406 B410134407 B410134408 B410134409 B410134410 B410134412 B410134413 B409134371 B410134456 B411134457 B411134458 B411134460 B411134461 B411134463 B411134464 B411134465 B411134467 B411134470 B411134472 B411134473 B411134475 B411134477 B411134478 B411134479 B411134480 B411134481 B411134482 B411134483 B411134484 B411134487 B411134488 B411134490 B411134492 B411134493 B411134495 B411134496 B411134497 B411134498 B411134499 B411134501 B411134502 B415123331 B411134468 B412134577 B412134579 B412134580 B413134639 B413134664 B412134575 B412134583 B412134587 B412134594 B412134598 B412134608 B412134613 B413134627 B418135262 B419135293 B419135320 B419135366 B421135540 B422135619 B422135630 B422135631 B422135643 B422135647 B422135658 B422135661 B422135664 B422135668 B422135671 B422135674 B422135678 B422135680 B422135683 B426136203 B426136204 B426136205 B426136206 B426136207 B426136208 B426136209 B426136210 B426136211 B426136212 B426136213 B426136214 B426136215 B426136216 B426136217 B426136218 B426136219 B426136220 B426136221 B426136222 B426136223 B426136224 B426136225 B451113128 B411134485 B426136202 B427136343 B428136402 B429136523 B429136527 B429136564 B429136566 B429136579 B430136649 B449123898 B416135083 B450123978
• 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: 245
• 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.