Class 2 Device Recall Newport e360 Ventilator

• Date Initiated by Firm: December 15, 2008
• Date Posted: September 04, 2009
• Recall Status: Terminated on November 04, 2011
• Recall Number: Z-2029-2009
• Recall Event ID: 50785
• 510(K)Number: K053502
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Newport e360 Ventilator, Rx only. ; ; The e360 Ventilator System is intended to provide continuous; (endotracheal or tracheostomy [ET] tube) or non-continuous; (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).
• Code Information: Serial Numbers for the Domestic Units: N07361211863 N06360910375 N06360610268 N09360413995 N07360110859 N07361111725 N07361111620 N06360710310 N06360710311 N06360710312 N07360110797 N08360812873 N06361210693 N07360911465 N36360410225 N07360110864 N07360110870 N09360313832 N07361111713 N08360512383 N08360512384 N08360512385 N08360512386 N07361211793 N06360910351 N08360712658 N08360712659 N08360712660 N08360712661 N08360712662 N08361013165 N08361013166 N08361013167 N08361013168 N08361013169 N06361210693 N07360110855 N08361213295 N09360113451 N06360610258 N07360110853 N06360610271 N06361010529 N06361010532 N07360110825 N07360811393 N08360212053 N07361211869 N07361211870 N07361211871 N07361211872 N09360213550 N06360810339 N06360910350 N06360910352 N06360910354 N06360910388 N06360910389 N07360411127 N07360811396 N07361111626 N07361111627 N07361111711 N07361111712 N08360512396 N08360612528 N08360612561 N08360712687 N08360712688 N08360712689 N08360712690 N08360712691 N08360712692 N08360712693 N08360712694 N08360712695 N08360712696 N08360712697 N08360712698 N08360712699 N08360712700 N08360712701 N08360712702 N08360712703 N08360712704 N08360712705 N08360712706 N08360712707 N08360712708 N08360712709 N08360712710 NO8360712709 N06360710307 N06360710308 N06360710309 N06360710313 N06360710314 N06360610280 N06361010516 N06361010518 N06361010519 N06361010522 N06361010536 N07360110856 N07360110862 N07360110867 N07360210926 N07360911464 N07360911489 N07360911490 N07360210952 N07360210953 N07360210954 N08361013107 N08361013108 N08361013109 N08361213283 N08361213284 N08360512381 N08360512382 N08360512398 N08360512399 N08360512400 N08360512402 N06361010542 N06361010543 N06361010544 N06361010545 N06361010546 N06361010547 N06361010548 N06361010550 N06361110551 N06361110552 N06361110553 N06361110554 N06361110555 N06361110556 N06361110557 N06361110558 N06361110559 N06361110560 N06361110561 N06361110562 N06361110563 N06361110564 N06361110572 N06360910373 N07306011235 N07360611236 N07360711360 N07360711361 N07360711363 N07360711364 N07360711368 N07360711372 N07360911491 N07360911492 N07361211769 N07361211783 N07361211784 N07361211785 N07361211786 N07361211787 N07361211788 N07361211789 N07361211790 N07361211791 N07361211792 N08360111874 N08360111875 N08360512395 N08361013110 N08361013111 N08361013112 N08361013113 N08361013114 N07360110873 N06361010536-R N07361211812 N07361211813 N08361013175 N08360111987 N08360111988 N08360111989 N08360111990 N06361010533 N07360110796 N07360110852 N07360110860 N07360110868 N07360110876 N06361010531 N07360210951 N07360210964 N07360110866 N07360811397 N07360110898 N07360210944 N07360811380 N07360811384 N07360811386 N07360811398 N07360811401 N07360811402 N07360811403 N07360811427 N08360811403 N07360711362 N07360711365 N07360811387 N09360213549 N06361010534 N07360110863; and Serial Numbers for the International Units: N06360910392 N06360910400 N06360910426 N06361110580 N07361111637 N07361111638 N09360313710 N06360910352 N07360110878 N07360411101 N07360611242 N07360611243 N07360611244 N07361211794 N07361211795 N07361211796 N07361211797 N07361211798 N08360111890 N08360111891 N08360111893 N08360111894 N08360612578 N08360612579 N08360612580 N08360612581 N08360612582 N08360612583 N08360612593 N08360712711 N08360712712 N08360712713 N09360313786 N09360313787 N07360311089 N07360411096 N07360411105 N07360411111 N07360411129 N07360511161 N07361011506 N07361011507 N07361011523 N07361011524 N07361011525 N07361011526 N07361011527 N07361011528 N07361011529 N07361011530 N07361011531 N07361011532 N07361011533 N07361011534 N07361011535 N07361011537 N07361011538 N07361011539 N07361011540 N07361011541 N07361011542 N07361011543 N07361011544 N07360210959 N08360812800 N08360812801 N08360812804 N08360812809 N08360812810 N08360812811 N08360812812 N08360812813 N08360812816 N08360812817 N08360812818 N08360812819 N08360812820 N08360812823 N08360812824 N09360213600 N09360313696 N09360313727 N09360313728 N09360313729 N09360313731 N09360313847 N09360413942 N09360413943 N09360413944 N09360413945 N09360413946 N09360414002 N09360414003 N06360610265 N07360210963 N07360210966 N07360210967 N07360210968 N07360210970 N09360113452 N07360110885 N07360110891 N07360110909 N07360210972 N07360311090 N07360311091 N07360411095 N07360411107 N07360411108 N08360312183 E360-0408-183 E360-0408-191 E360-0408-195 E360-0408-202 E360-0508-003 E360-0508-006 E360-0508-012 E360-0508-017 E360-0508-018 E360-0508-019 E360-0508-020 E360-0508-021 E360-0508-023 E360-0508-024 E360-0508-025 E360-0508-026 E360-0508-027 E360-0508-028 E360-0508-029 E360-0508-030 E360-0508-031 E360-0508-032 E360-0508-033 E360-0508-034 E360-0508-035 E360-0508-036 E360-0508-037 E360-0508-038 E360-0508-039 E360-0508-041 E360-0508-042 E360-0508-043 E360-0508-044 E360-0508-045 E360-0508-047 E360-0508-048 E360-0508-049 E360-0508-050 E360-0508-052 E360-0508-053 E360-0508-054 E360-0508-056 E360-0508-057 E360-0508-058 E360-0508-059 E360-0508-060 E360-0508-061 E360-0508-062 E360-0508-063 E360-0508-064 E360-0508-065 E360-0508-066 E360-0508-070 E360-0808-126 E360-0808-172 E360-0908-056 E360-0908-109 E360-0908-118 E360-0908-131 E360-0908-137 E360-0908-138 E360-0908-148 E360-0908-153 E360-0908-154 E360-0908-164 E360-0908-167 E360-0908-172 E360-0908-174 E360-0908-183 E360-0908-187 E360-0908-188 E360-0908-189 E360-1008-001 E360-1008-004 E360-1008-005 E360-1008-006 E360-1008-008 E360-1008-009 E360-1008-012 E360-1008-014 E360-1008-015 E360-1008-018 E360-1008-019 E360-1008-027 E360-1008-029 E360-1008-030 E360-1008-031 E360-1008-034 E360-1008-035 E360-1008-036 E360-1008-038 E360-1008-045 E360-1008-046 E360-1008-050 E360-1008-051 E360-1008-052 E360-1008-054 E360-1008-055 E360-1008-057 E360-1008-061 E360-1008-062 E360-1008-067 E360-1008-070 E360-1008-071 E360-1008-072 E360-1008-073 E360-1008-077 E360-1008-078 E360-1008-079 E360-1008-080 E360-1008-081 E360-1008-083 E360-1008-084 E360-1008-085 E360-1008-086 E360-1008-087 E360-1008-089 E360-1008-091 E360-1008-092 E360-1008-095 E360-1008-096 E360-1008-097 E360-1008-098 E360-1008-099 E360-1008-100 E360-1008-101 E360-1008-102 E360-1008-103 E360-1008-104 E360-1008-106 E360-1008-107 E360-1008-108 E360-1008-109 E360-1008-110 E360-1008-112 E360-1008-113 E360-1008-114 E360-1008-115 E360-1008-117 E360-1008-119 E360-1008-120 E360-1008-121 E360-1008-122 E360-1008-123 E360-1008-124 E360-1008-125 E360-1008-126 E360-1008-129 E360-1008-130 E360-1008-131 E360-1008-132 E360-1008-137 E360-1008-140 E360-1008-144 E360-1008-145 E360-1008-146 E360-1008-148 E360-1008-151 E360-1008-152 E360-1008-155 E360-1008-156 E360-1008-159 E360-1008-160 E360-1008-161 E360-1108-008 E360-1108-014 E360-1108-015 E360-1108-016 E360-1108-017 E360-1108-018 E360-1108-019 E360-1108-020 E360-1108-021 E360-1108-022 E360-1108-023 E360-1108-024 E360-1108-025 E360-1108-026 E360-1108-027 E360-1108-028 E360-1108-031 E360-1108-032 E360-1108-033 E360-1108-034 E360-1108-036 E360-1108-037 E360-1108-044 E360-1108-045 E360-1108-047 E360-1108-048 E360-1108-049 E360-1108-050 E360-1108-051 E360-1108-052 E360-1108-055 E360-1108-056 E360-1108-057 E360-1108-058 E360-1108-059 E360-1108-060 E360-1108-061 E360-1108-062 E360-1108-063 E360-1108-064 E360-1108-065 E360-1108-066 E360-1108-067 E360-1108-068 E360-1108-072 E360-1108-073 E360-1108-074 E360-1108-075 E360-1108-076 E360-1108-077 E360-1108-078 E360-1108-079 E360-1108-081 E360-1108-084 E360-1108-085 E360-1108-087 E360-1108-088 E360-1108-092 E360-1108-096 E360-1108-098 E360-1108-100 E360-1108-101 E360-1108-157 E360-1108-163 E360-1108-164 E360-1108-167 E360-1108-171 E360-1108-173 E360-1108-178 E360-1108-180 E360-1108-181 E360-1108-182 E360-1108-186 E360-1108-192 E360-1208-019 E360-1208-020 E360-1208-021 E360-1208-023 E360-1208-025 E360-1208-026 E360-1208-027 E360-1208-030 E360-1208-031 E360-1208-037 E360-1208-041 E360-1208-044 E360-1208-052 E360-1208-054 E360-1208-058 E360-1208-059 E360-1208-061 E360-1208-062 E360-1208-069 E360-1208-072 E360-1208-078 E360-1208-085 E360-1208-087 E360-1208-090 E360-1208-093 E360-1208-094 E360-1208-099 E360-1208-101 E360-1208-102 E360-1208-103 E360-1208-104 E360-1208-105 E360-1208-106 E360-1208-107 E360-1208-108 E360-1208-109 E360-1208-110 E360-1208-111 E360-1208-112 E360-1208-113 E360-1208-114 E360-1208-115 E360-1208-116 E360-1208-117 E360-1208-118 E360-1208-119 E360-1208-120 E360-1208-121 E360-1208-122 E360-1208-123 E360-1208-124 E360-1208-125 E360-1208-126 E360-1208-127 E360-1208-129 E360-1208-130 N07361111693 N07361111694 N07361111695 N07361111696 N07361111697 N07361111722 N07361111723 N07361111724 N07361111730 N07361111731 N07361111732 N07361111736 N07361111737 N07361111738 N07361111739 N07361111740 N07361111741 N07361111742 N07361111743 N07361111744 N07361111745 N07361111746 N07361111747 N07361111748 N07361111750 N07361111754 N07361111755 N07361111756 N07361111757 N07361111758 N07361111759 N07361111760 N07361111761 N07361111762 N07361111763 N07361111764 N07361111765 N07361111766 N07361111767 N07361111768 N08360912976 N08360913020 N08360913021 N08360913022 N08360913023 N08360913024 N08360913025 N08360913026 N08360913027 N08360913028 N08360913029 N08360913030 N08360913031 N08360913032 N08360913033 N08360913034 N08360913035 N08360913036 N08360913037 N08360913038 N08360913039 N08360913040 N08360913041 N08360913042 N08360913043 N08360913044 N08360913045 N08360913046 N08360913047 N08360913048 N08360913049 N08360913050 N08360913051 N08360913052 N08360913055 N08360913056 N08360913057 N08360913058 N08360913059 N08360913060 N08360913061 N08360913062 N08360913063 N08360913065 N08360913066 N08360913067 N08360913068 N08360913069 N08360913070 N08360913071 N08360913072 N08360913073 N08360913074 N08360913075 N08360913076 N08360913077 N08360913078 N08360913079 N08360913080 N08360913081 N05361110106 N06360310212 N06360710293 N06360710296 N06360710305 N06360710306 N06361010541 N08360111957 N08360111958 N08360812838 N06361210660 N09360413997 N06360910373 N06360910398 N06361010516 N07360911465 N07361211775 N08360212066 N08360212067 N08360212068 N08360212069 N08360612521 N08360612522 N08360612523 N08360612524 N08360612525 N08360612526 N08360712675 N09360413993 N06360610250 N06361010478 N06361110629 N07360110829 N07360110830 N07360210961 N07360210962 N07361011554 N07361111728 N07361111749 N07361211824 N07360811404 N08360913064 N07360210945 N06360910380 N06360910379 N07360210936 N06360910387 N07360611245 N07360611246 N07360611292 N07360711318 N07360711321 N07360711322 N08361013124 N08361013125 N08361013126 N08361013127 N08361013128 N08361013129 N08361013130 N08361013131 N08361013137 N08361013138 N08361013142 N08361013143 N08361013144 N08361013145 N08361013146 N08361013147 N09360413983 N09360413984 N09360413985 N09360413986 N09360413987 N09360413988 N09360413989 N09360413990 N07361111682 N06360810331 N06360810334 N06361010473 N06361010481 N07360711317 N07360811412 N07360811414 N07360811416 N07360911469 N07360911471 N07360911472 N07360911473 N07360911474 N07360911475 N07360911476 N07360911485 N07360911486 N07360911487 N07360911488 N07361011589 N07361011590 N07361011591 N08360913000 N08360913001 N08361013105 N08361013106 N09360113411 N09360113412 N09360113413 N09360113414 N09360213551 N09360213552 N09360213554 N09360213555 N06360810326 N06360810332 N06360810335 N06361110582 N07360110889 N07360110890 N07361211772 N07361211773 N08360111876 N08360111886 N08360111887 N08360111888 N08360111889 N08360111892 N08360111895 N08360111896 N08360111897 N08360111898 N08360111899 N08360312155 N08360312157 N08360312158 N08360312159 N08360312160 N08360312161 N08360312162 N08360312163 N08360312182 N08360612586 N08360612587 N08360612588 N08360612589 N08360612590 N08360712715 N08360712716 N08360712718 N08360912995 N08360912996 N08360912997 N08360913002 N08360913005 N08360913007 N08360913008 N08360913009 N08360913010 N08361113248 N08361113249 N08361113250 N08361113251 N08361113252 N08361213384 N08361213385 N08361213386 N08361213387 N08361213388 N08361213389 N08361213390 N08361213391 N08361213392 N08361213393 N08361213394 N08361213395 N08361213396 N08361213397 N08361213398 N08361213399 N08361213400 N06361210647 N06361210658 N06360210210* N06360610256 N06360610262 N06361010526 N06361010527 N07360110914 N07360511139 N07360511160 N07360811373 N07360811395 N07360811407 N07361011516 N07361111621 N07361111622 N07361111623 N07361111628 N08360312131 N08360512378 N08360512401 N08360612562 N08360612563 N08360612564 N08360612565 N08360612566 N08360612567 N08360612568 N08360612569 N08360612570 N08360612571 N08360612572 N08360612573 N08360612574 N08360612575 N08360612576 N08360612577 N08360812825 N08360812828 N08360812829 N08360812830 N08360812831 N08360812832 N08360812833 N08360812834 N08360812835 N08360812836 N08360812837 N08360812839 N08360812840 N08360812841 N08360812842 N08360812843 N08360812844 N08360812851 N08360812859 N08360812860 N08360812861 N08360812868 N08360812869 N08360812870 N08360812871 N08360812872 N08360812875 N08360812876 N08360812877 N08360812878 N08360912896 N08360912897 N08360912898 N08360912899 N08360912900 N08360912901 N08360912902 N08360912903 N08360912904 N08360912905 N08360912906 N08360912907 N08360912908 N08360912909 N08360912913 N08360912914 N08360912916 N08360912920 N08360912921 N08360912926 N08360912927 N08360912957 N08361013161 N08361013162 N08361113183 N08361113184 N09360113500 N09360113501 N08360312174 N08360612529 N08360612537 N08360612538 N08360612539 N08360612540 N08360612541 N08360612542 N08360612543 N08360612544 N08360612545 N08360612546 N08360612547 N08361013160 N08361013164 N07360611276 N07360611294 N07360611296 N07360611300 N07360611304 N07360611305 N07360611306 N07360611308 N07360611309 N07360611310 N07360611311 N07360611312 N07360611313 N07360611314 N07360611315 N07360711329 N07360711330 N07360711332 N07360711333 N07360711334 N07360711335 N07360711336 N07360711337 N07360711338 N07360711339 N07360711340 N07360711342 N07360711343 N07360711344 N07360711345 N07360711346 N07360711347 N07360711348 N07360711353 N07360811377 N07360811383 N07360811388 N06360910374 N06360910376 N07360110913 N07361011515 N08360412243 N08360412244 N08360612637 N08360612645 N08360712762 N08360712763 N08360912960 N08361013094 N09360213567 N06360910434 N06360910439 N06360910445 N06361010465 N06361010491 N06361010537 N06361010538 N06361010539 N06361010540 N06361210634 N07361211810 N06361110618 N08360312227 N09360313709 N06360210205 N06360210208 N06360210209 N06360210214 N06360310211 N06360310218 N06360310218 N06360310220 N06360610253 N07360110831 N07360110832 N07360110834 N07360110835 N07360110893 N07360210965 N07360411102 N07360411104 N07360411106 N07360411110 N07360411112 N07360411113 N07360411114 N07360411115 N07360411116 N07360411117 N07360411118 N07360411119 N07360411120 N07360411121 N07360411122 N07360411123 N07360411124 N07360411125 N07360411126 N07360511130 N07360511142 N07360511143 N07360511144 N07360511145 N07360511146 N07360511147 N07360511148 N07360511149 N07360511150 N07360511151 N07360511152 N07360511153 N07360511154 N07360511155 N07360511156 N07360511163 N07360511164 N07360511165 N07360511166 N07360511167 N07360511168 N07360511169 N07360511170 N07360511171 N07360511172 N07360511173 N07360511174 N07360511175 N07360511176 N07360511177 N07360511185 N07360511186 N07360511187 N07360511190 N07360511191 N07360511192 N07360511193 N07360511194 N07360511195 N07360511200 N07360511201 N07360611257 N07360611258 N07360611259 N07360611260 N07360611261 N07360611262 N07360611263 N07360611264 N07360611265 N07360611266 N07360611267 N07360611268 N07360611269 N07360611270 N07360611271 N07360611272 N07360611273 N07360611274 N07360611275 N08360111877 N08360111878 N08360111879 N08360111880 N08360111881 N08360111882 N08360111883 N08360111884 N08360111885 N08360111910 N08360111911 N08360111912 N08360111913 N08360111914 N08360111915 N08360111916 N08360111917 N08360111929 N08360111930 N08360111931 N08360111932 N08360111933 N08360111934 N08360111935 N08360111936 N08360111937 N08360111946 N08360111947 N08360111948 N08360111949 N08360111950 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N09360213556 N09360213561 N09360213606 N09360213610 N07360210922 and N07360110840.
• Recalling Firm/ Manufacturer: Newport Medical Instruments Inc; 1620 Sunflower Ave; Costa Mesa CA 92626
• For Additional Information Contact: 714-427-5811
• Manufacturer Reason for Recall: In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms. Newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. Newport condu
• FDA Determined Cause: Software design
• Action: Newport Medical initally sent out a Field Correction Notice to a limited number consignees dated December 17, 2008 and then the notice was expanded to include all e360 consignees dated June 15, 2009. The firm notified consignees that they have revised the e360 software to version 3.8. A customer verification form was attached to verify upgrade completion. For further questions, contact Newport Customer Technical Support Department at 1-800-451-3111 or +1-714-427-5811 Extension 500.
• Quantity in Commerce: 4,117 units (214 Domestically; 3,903 Internationally)
• Distribution: Worldwide Distribution -- US (including AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, ME, MI, NJ, NM, NY, OH, OK, OR, PA, UT and VA), Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, England, Finland, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Japan, Jordan, Kazahkstan, Kenya, Korea, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nambia, Nepal, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, AUE, Ukraine, United Kingdom, Yemen Republic and Zimbabwe.
• 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 = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.