| Class 2 Device Recall CAPNOSTREAM 20P (US) N W/PRINTER | |
Date Initiated by Firm | July 31, 2018 |
Create Date | October 03, 2018 |
Recall Status1 |
Terminated 3 on September 20, 2022 |
Recall Number | Z-0026-2019 |
Recall Event ID |
80895 |
510(K)Number | K112368 |
Product Classification |
Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
|
Product | CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 |
Code Information |
B400002777 B400002778 B400002779 B400002780 B400002781 B400002782 B400002783 B400002784 B400002785 B400002786 B600002902 B600002903 B600002905 B600002906 B600002908 B600002901 B600002904 B600002907 B632123517 B633123526 B621135542 B621135543 B621135544 B621135545 B621135546 B621135547 B621135548 B621135549 B621135550 B621135551 B621135552 B621135553 B621135554 B621135555 B621135556 B621135557 B621135558 B621135559 B621135560 B621135561 B621135562 B621135564 B621135566 B621135568 B621135569 B621135570 B621135571 B621135572 B621135573 B621135574 B621135575 B621135577 B621135578 B621135580 B621135582 B621135583 B621135584 B621135585 B621135586 B621135587 B621135589 B621135590 B621135591 B621135592 B621135594 B621135595 B621135588 B621135593 B633137055 B633137058 B633137060 B633137061 B633137062 B633137063 B633137064 B633137065 B633137066 B633137068 B633137069 B634137070 B634137071 B634137072 B634137073 B634137074 B634137075 B634137076 B634137077 B634137078 B634137079 B634137080 B638137579 B638137585 B638137586 B638137592 B638137593 B642138043 B642138046 B642138048 B642138052 B642138055 B642138056 B642138058 B642138060 B642138062 B642138063 B642138065 B642138066 B642138068 B642138069 B642138070 B642138071 B642138072 B642138074 B642138075 B642138078 B642138082 B642138083 B642138084 B642138086 B642138087 B642138088 B642138089 B642138090 B642138091 B642138092 B642138095 B642138096 B642138098 B642138100 B642138101 B642138102 B642138103 B642138104 B642138106 B642138110 B642138111 B642138112 B600002899 B605148494 B605148497 B605148498 B605148502 B605148504 B605148505 B605148507 B605148508 B605148509 B605148512 B605148513 B605148514 B605148516 B605148517 B605148518 B605148519 B605148522 B605148524 B606148526 B606148528 B606148529 B606148532 B606148533 B606148535 B606148536 B606148537 B633137059 B638137549 B638137551 B638137557 B638137558 B638137560 B638137561 B638137563 B638137565 B638137566 B638137570 B638137577 B638137583 B638137588 B638137590 B638137591 B638137595 B638137596 B642138014 B642138015 B642138016 B642138067 B642138105 B605148506 B605148510 B605148511 B605148515 B605148520 B605148521 B605148523 B606148527 B606148530 B606148534 B606148538 B606148539 B606148540 B606148541 B606148542 B606148543 B606148546 B606148547 B606148548 B606148549 B606148550 B606148553 B606148554 B606148558 B606148560 B606148562 B606148566 B606148568 B606148571 B606148574 B606148579 B606148581 B606148582 B606148583 B606148584 B606148585 B606148586 B607148639 B621135563 B621135579 B633135601 B633137067 B638137564 B638137580 B642138017 B642138044 B642138049 B605148525 B606148531 B606148544 B606148545 B606148552 B606148556 B606148557 B606148559 B606148561 B606148563 B606148564 B606148565 B606148569 B606148570 B606148573 B606148575 B606148577 B607148640 B607148647 B607148649 B608148650 B608148651 B608148654 B608148655 B608148656 B608148657 B608148659 B608148661 B608148666 B608148668 B608148678 B608148679 B608148711 B608148712 B608148713 B608148714 B608148715 B608148716 B608148717 B608148720 B608148722 B608148724 B608148725 B608148726 B609148727 B609148728 B642138047 B642138093 B605148496 B605148501 B606148587 B607148641 B607148642 B607148648 B608148653 B608148658 B608148662 B608148663 B608148667 B608148670 B608148672 B608148673 B608148674 B608148675 B608148676 B608148680 B608148681 B608148683 B608148684 B608148685 B608148686 B608148687 B608148689 B608148693 B608148694 B608148698 B608148700 B608148701 B608148702 B608148706 B608148709 B608148710 B608148718 B608148723 B609148729 B605148495 B605148499 B605148500 B606148551 B606148567 B606148572 B606148576 B606148578 B607148643 B607148644 B607148645 B607148646 B608148652 B608148660 B608148664 B608148665 B608148669 B608148671 B608148677 B608148682 B608148688 B608148690 B608148691 B608148692 B608148695 B608148696 B608148697 B608148703 B608148704 B608148705 B608148707 B608148708 B608148719 B608148721 B612149029 B612149030 B612149031 B612149032 B612149033 B612149034 B612149035 B612149036 B638137555 B612148984 B612149001 B612149005 B612149007 B612149010 B612149012 B612149013 B612149016 B612149019 B612149026 B616149190 B616149195 B616149196 B616149201 B616149202 B616149203 B616149205 B616149206 B616149207 B616149208 B616149211 B616149214 B616149215 B616149219 B616149220 B616149221 B616149228 B616149229 B616149242 B616149248 B605148503 B612149037 B616149191 B616149192 B616149194 B616149197 B616149198 B616149210 B616149212 B616149230 B616149231 B616149232 B616149234 B616149235 B616149236 B616149237 B616149238 B616149239 B616149240 B616149241 B616149243 B616149244 B616149245 B616149246 B616149247 B616149249 B616149250 B616149251 B616149252 B616149253 B616149254 B616149255 B616149256 B616149257 B616149258 B616149259 B615149043 B615149127 B616149147 B616149270 B616149278 B616149279 B616149289 B619149290 B619149294 B619149297 B619149299 B619149300 B619149301 B619149302 B619149304 B619149306 B619149307 B619149309 B619149310 B619149311 B619149312 B619149313 B619149314 B619149315 B619149317 B619149318 B619149319 B619149320 B619149321 B619149323 B619149324 B619149325 B619149326 B619149327 B619149329 B619149330 B619149332 B619149333 B619149334 B619149335 B619149336 B619149337 B619149339 B619149340 B619149341 B619149342 B619149344 B620149366 B620149394 B620149395 B620149396 B620149400 B620149404 B620149413 B620149414 B620149418 B620149437 B620149439 B620149442 B620149452 B615149042 B619149291 B619149322 B619149345 B619149347 B619149348 B619149351 B619149352 B619149354 B619149355 B620149358 B620149361 B620149365 B620149367 B620149368 B620149370 B620149371 B620149372 B620149375 B620149377 B620149381 B620149383 B620149385 B620149386 B620149390 B620149392 B620149393 B620149398 B620149399 B620149401 B620149405 B620149409 B620149410 B620149412 B620149415 B620149416 B620149417 B620149420 B620149421 B620149426 B620149431 B620149433 B620149434 B620149441 B620149443 B620149446 B620149449 B620149451 B616149286 B619149292 B619149316 B619149328 B619149331 B619149338 B619149343 B619149346 B619149349 B619149350 B619149353 B619149356 B619149357 B620149359 B620149360 B620149362 B620149364 B620149369 B620149373 B620149374 B620149376 B620149379 B620149380 B620149382 B620149388 B620149391 B620149397 B620149408 B620149411 B620149419 B620149425 B620149432 B620149435 B620149445 B620149450 B620149455 B620149456 B620149458 B620149459 B620149461 B620149464 B621149467 B621149470 B621149473 B621149477 B621149478 B621149481 B621149482 B616149222 B619149303 B620149363 B620149378 B620149384 B620149387 B620149389 B620149406 B620149407 B620149422 B620149424 B620149427 B620149428 B620149429 B620149436 B620149438 B620149440 B620149444 B620149447 B620149448 B620149453 B620149454 B620149457 B620149460 B620149462 B620149463 B621149465 B621149466 B621149468 B621149469 B621149471 B621149472 B621149474 B621149476 B621149479 B621149483 B621149484 B621149485 B621149486 B621149487 B621149488 B621149489 B621149490 B621149491 B639137664 B639137665 B639137667 B639137668 B639137669 B639137670 B639137672 B639137675 B639137676 B639137677 B639137679 B639137681 B639137683 B639137685 B639137686 B639137687 B639137689 B639137690 B639137692 B639137693 B616149268 B619149293 B619149308 B621149480 B625140086 B625140103 B625149943 B625149968 B625149993 B625149995 B625149998 B626140104 B626140105 B626140106 B626140108 B626140110 B625140095 B625140097 B625140099 B625140100 B625140102 B625149949 B625149980 B625149987 B626140107 B626140109 B626140111 B626140112 B626140113 B626140114 B626140115 B626140116 B626140117 B626140118 B626140119 B626140121 B626140122 B626140123 B626140124 B626140125 B626140126 B626140127 B626140128 B626140129 B626140130 B626140131 B626140132 B626140133 B626140134 B626140135 B626140136 B626140137 B626140138 B626140139 B626140140 B626140142 B626140143 B626140144 B626140145 B626140146 B626140147 B626140148 B626140149 B626140150 B626140151 B626140152 B626140153 B626140154 B626140155 B626140156 B626140157 B626140158 B626140159 B626140160 B626140161 B626140162 B626140163 B626140164 B626140166 B626140167 B626140168 B623149756 B626140120 B626140141 B626140165 B626140192 B626140193 B626140194 B626140195 B626140196 B626140197 B626140200 B626140201 B626140202 B626140203 B626140204 B626140205 B626140206 B626140207 B626140208 B626140210 B626140211 B626140212 B626140213 B626140214 B626140215 B626140216 B626140198 B626140209 B627140249 B627140250 B627140251 B627140252 B627140253 B627140254 B627140255 B627140257 B627140258 B627140259 B627140260 B627140261 B627140262 B627140263 B627140264 B627140265 B627140266 B627140267 B627140268 B627140269 B627140270 B627140271 B627140274 B627140275 B627140277 B627140278 B627140279 B627140280 B627140281 B627140282 B627140283 B627140284 B627140286 B627140287 B627140288 B627140289 B627140290 B627140291 B627140292 B627140293 B627140294 B627140273 B627140276 B627140295 B627140296 B627140297 B627140299 B627140300 B627140302 B627140303 B627140304 B627140305 B627140306 B628140307 B628140308 B628140309 B628140310 B628140311 B628140312 B628140313 B628140314 B628140315 B628140316 B628140317 B628140318 B628140320 B628140321 B628140322 B628140323 B628140324 B628140326 B628140327 B628140329 B628140331 B629140332 B629140333 B629140334 B629140335 B629140336 B629140337 B629140338 B629140339 B629140341 B629140342 B629140343 B629140344 B629140345 B629140346 B629140347 B629140348 B629140349 B629140350 B629140351 B629140353 B629140354 B629140355 B629140356 B629140357 B629140358 B629140359 B629140360 B629140362 B629140363 B629140364 B629140365 B629140366 B629140367 B629140368 B629140369 B629140370 B629140371 B629140372 B629140373 B621135581 B627140256 B627140272 B627140298 B628140319 B628140325 B628140328 B628140330 B629140340 B629140352 B632140912 B632140915 B632140916 B632140917 B632140918 B632140919 B632140920 B632140921 B632140922 B632140925 B632140927 B632140928 B632140929 B632140930 B633140931 B633140933 B633140937 B633140939 B633140940 B633140941 B633140947 B633140950 B634140962 B634140979 B632140875 B632140887 B632140889 B632140890 B632140894 B632140896 B632140898 B632140900 B632140901 B632140902 B632140903 B632140904 B632140906 B632140907 B632140908 B632140909 B632140910 B632140911 B632140913 B632140923 B633140934 B633140944 B633140949 B634140985 B627140285 B627140301 B632140869 B632140870 B632140872 B632140873 B632140874 B632140876 B632140877 B632140878 B632140879 B632140880 B632140881 B632140882 B632140883 B632140884 B632140885 B632140886 B632140888 B632140891 B632140892 B632140893 B632140895 B632140897 B632140899 B632140905 B632140924 B632140926 B633140932 B633140935 B633140936 B633140942 B633140943 B633140945 B633140946 B633140948 B633140952 B634140954 B634140957 B634140958 B634140959 B634140964 B634140974 B634140980 B634140987 B632140871 B632140914 B633140938 B633140951 B633140953 B634140955 B634140960 B634140961 B634140963 B634140965 B634140966 B634140967 B634140968 B634140969 B634140970 B634140971 B634140972 B634140973 B634140975 B634140976 B634140977 B634140978 B634140981 B634140982 B634140983 B634140984 B634140986 B634140988 B634140989 B634140990 B634140991 B634140992 B634140993 B634140994 B634140995 B634140996 B634140997 B634140998 B634140999 B634141000 B634141001 B634141002 B634141003 B634141004 B634141005 B634141006 B634141007 B634141008 B608148699 B620149403 B625140091 B625149954 B625149969 B629140361 B633137056 B633137057 B634140956 B639137666 B639137674 B639137678 B639137680 B639137682 B639137684 B639137688 B639137691 |
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 | 1038 |
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.
|
510(K) Database | 510(K)s with Product Code = CCK
|
|
|
|