Varian Medical Systems, Inc. Oncology Systems: Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Recall number

Z-0483-2012

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Product

Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Status

Terminated

Initiated

2011-11-28

Posted

2012-01-11

Terminated

2015-06-02

Reason

An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.

Root cause

Device Design

Action

Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated November 28, 2011 ***Expanded to include product #2 on December 16, 2011***, to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to establish a comprehensive quality assurance program before beginning treatments for the day, quality assurance tests must be performed. Additionally, any discrepancies in imaging field sizes vs planned field size should be brought to the attention of the medical physicist for investigation before treatment continues. Customers were asked to complete the attached Proof of Notification or Receipt Verification Card once they have read the document and return it to Varian Medical Systems. For question regarding this recall: USA and Canada 1-888-827-4265 Europe +41 41 749 8844

Quantity

6158 units total

Distribution

Worldwide Distribution

Lot, serial or model codes

H140001 ,H140145 ,H140711 ,H140772 ,H140832 ,H140893 ,H140958 ,H271265 ,H271742 ,H272014 ,H272235 ,H272416 ,H272858  ,H140011 ,H140146 ,H140712 ,H140773 ,H140833 ,H140895 ,H140959 ,H271277 ,H271755 ,H272016 ,H272236 ,H272418 ,H272859  ,H140018 ,H140147 ,H140713 ,H140774 ,H140834 ,H140896 ,H140962 ,H271293 ,H271760 ,H272023 ,H272237 ,H272421 ,H272860  ,H140025 ,H140148 ,H140714 ,H140775 ,H140835 ,H140897 ,H140963 ,H271308 ,H271762 ,H272029 ,H272239 ,H272422 ,H272862  ,H140026 ,H140150 ,H140715 ,H140776 ,H140836 ,H140898 ,H180455 ,H271334 ,H271763 ,H272031 ,H272240 ,H272423 ,H272864  ,H140027 ,H140151 ,H140716 ,H140777 ,H140837 ,H140899 ,H182000 ,H271362 ,H271773 ,H272033 ,H272243 ,H272425 ,H272866  ,H140029 ,H140152 ,H140717 ,H140778 ,H140838 ,H140900 ,H182001 ,H271370 ,H271780 ,H272035 ,H272250 ,H272426 ,H272868  ,H140031 ,H140153 ,H140718 ,H140779 ,H140839 ,H140901 ,H182002 ,H271378 ,H271783 ,H272043 ,H272259 ,H272427 ,H272872  ,H140038 ,H140154 ,H140719 ,H140780 ,H140840 ,H140902 ,H182003 ,H271385 ,H271785 ,H272045 ,H272260 ,H272428 ,H272873  ,H140039 ,H140201 ,H140720 ,H140781 ,H140841 ,H140903 ,H182005 ,H271393 ,H271797 ,H272049 ,H272271 ,H272432 ,H272876  ,H140043 ,H140202 ,H140721 ,H140782 ,H140842 ,H140904 ,H182006 ,H271407 ,H271801 ,H272050 ,H272277 ,H272434 ,H272885  ,H140045 ,H140203 ,H140722 ,H140783 ,H140843 ,H140905 ,H182007 ,H271413 ,H271802 ,H272052 ,H272283 ,H272438 ,H272889  ,H140046 ,H140204 ,H140723 ,H140784 ,H140844 ,H140906 ,H182008 ,H271414 ,H271811 ,H272062 ,H272290 ,H272440 ,H272890  ,H140047 ,H140205 ,H140724 ,H140785 ,H140845 ,H140907 ,H182009 ,H271420 ,H271825 ,H272064 ,H272291 ,H272444 ,H272893  ,H140048 ,H140206 ,H140725 ,H140786 ,H140846 ,H140908 ,H182010 ,H271425 ,H271831 ,H272069 ,H272293 ,H272445 ,H272899  ,H140058 ,H140207 ,H140726 ,H140787 ,H140847 ,H140909 ,H182011 ,H271429 ,H271833 ,H272078 ,H272299 ,H272446 ,H272905  ,H140062 ,H140208 ,H140727 ,H140788 ,H140848 ,H140910 ,H182012 ,H271438 ,H271835 ,H272081 ,H272301 ,H272454 ,H272908  ,H140067 ,H140209 ,H140728 ,H140789 ,H140849 ,H140911 ,H182013 ,H271439 ,H271838 ,H272085 ,H272302 ,H272456 ,H272909  ,H140070 ,H140210 ,H140729 ,H140790 ,H140850 ,H140912 ,H182014 ,H271440 ,H271845 ,H272086 ,H272306 ,H272458 ,H272910  ,H140071 ,H140211 ,H140730 ,H140791 ,H140851 ,H140913 ,H182016 ,H271443 ,H271853 ,H272089 ,H272307 ,H272460 ,H272911  ,H140073 ,H140212 ,H140731 ,H140792 ,H140852 ,H140914 ,H182017 ,H271452 ,H271856 ,H272111 ,H272309 ,H272462 ,H272912  ,H140076 ,H140213 ,H140732 ,H140793 ,H140853 ,H140915 ,H182018 ,H271490 ,H271858 ,H272115 ,H272310 ,H272464 ,H272914  ,H140077 ,H140214 ,H140733 ,H140794 ,H140854 ,H140916 ,H182019 ,H271497 ,H271860 ,H272118 ,H272311 ,H272466 ,H272922  ,H140078 ,H140215 ,H140734 ,H140795 ,H140855 ,H140917 ,H182020 ,H271502 ,H271862 ,H272129 ,H272313 ,H272469 ,H272926  ,H140079 ,H140216 ,H140735 ,H140796 ,H140856 ,H140918 ,H182021 ,H271507 ,H271866 ,H272134 ,H272318 ,H272470 ,H272932  ,H140088 ,H140217 ,H140736 ,H140797 ,H140857 ,H140919 ,H182022 ,H271515 ,H271870 ,H272136 ,H272321 ,H272473 ,H272933  ,H140090 ,H140218 ,H140737 ,H140798 ,H140858 ,H140920 ,H182023 ,H271519 ,H271872 ,H272137 ,H272324 ,H272476 ,H272936  ,H140092 ,H140219 ,H140738 ,H140799 ,H140859 ,H140921 ,H182030 ,H271523 ,H271875 ,H272138 ,H272325 ,H272479 ,H272938  ,H140096 ,H140220 ,H140739 ,H140800 ,H140860 ,H140922 ,H182032 ,H271526 ,H271877 ,H272143 ,H272326 ,H272480 ,H272941  ,H140097 ,H140221 ,H140740 ,H140801 ,H140861 ,H140923 ,H260905 ,H271531 ,H271879 ,H272153 ,H272327 ,H272488 ,H272946  ,H140098 ,H140222 ,H140742 ,H140802 ,H140862 ,H140924 ,H260909 ,H271534 ,H271881 ,H272155 ,H272328 ,H272491 ,H272951  ,H140101 ,H140223 ,H140743 ,H140803 ,H140863 ,H140925 ,H260922 ,H271559 ,H271890 ,H272156 ,H272329 ,H272492 ,H272953  ,H140107 ,H140224 ,H140744 ,H140804 ,H140864 ,H140926 ,H260924 ,H271582 ,H271893 ,H272157 ,H272333 ,H272494 ,H272956  ,H140109 ,H140225 ,H140745 ,H140805 ,H140865 ,H140927 ,H260925 ,H271587 ,H271895 ,H272158 ,H272336 ,H272497 ,H272960  ,H140111 ,H140226 ,H140746 ,H140806 ,H140866 ,H140929 ,H260928 ,H271588 ,H271896 ,H272159 ,H272339 ,H272500 ,H272961  ,H140113 ,H140227 ,H140747 ,H140807 ,H140867 ,H140930 ,H260931 ,H271593 ,H271903 ,H272162 ,H272341 ,H272801 ,H272963  ,H140114 ,H140228 ,H140748 ,H140808 ,H140868 ,H140931 ,H260936 ,H271594 ,H271905 ,H272163 ,H272343 ,H272803 ,H272964     ,H140115 ,H140229 ,H140749 ,H140809 ,H140869 ,H140932 ,H260940 ,H271602 ,H271906 ,H272168 ,H272345 ,H272804 ,H272968  ,H140116 ,H140230 ,H140750 ,H140810 ,H140870 ,H140933 ,H260942 ,H271607 ,H271918 ,H272169 ,H272346 ,H272805 ,H272971  ,H140117 ,H140231 ,H140751 ,H140811 ,H140871 ,H140934 ,H260946 ,H271618 ,H271921 ,H272172 ,H272349 ,H272806 ,H272973  ,H140118 ,H140232 ,H140752 ,H140812 ,H140872 ,H140935 ,H260949 ,H271624 ,H271926 ,H272173 ,H272354 ,H272811 ,H272978  ,H140119 ,H140233 ,H140753 ,H140813 ,H140873 ,H140936 ,H260950 ,H271626 ,H271931 ,H272174 ,H272355 ,H272816 ,H272981  ,H140121 ,H140234 ,H140754 ,H140814 ,H140874 ,H140937 ,H260951 ,H271628 ,H271935 ,H272178 ,H272359 ,H272820 ,H272982  ,H140122 ,H140235 ,H140755 ,H140815 ,H140875 ,H140938 ,H260952 ,H271635 ,H271941 ,H272179 ,H272360 ,H272822 ,H272985  ,H140124 ,H140236 ,H140756 ,H140816 ,H140876 ,H140939 ,H260953 ,H271640 ,H271942 ,H272180 ,H272362 ,H272824 ,H272986  ,H140125 ,H140237 ,H140757 ,H140817 ,H140877 ,H140940 ,H270767 ,H271662 ,H271951 ,H272184 ,H272365 ,H272825 ,H272987  ,H140129 ,H140238 ,H140758 ,H140818 ,H140878 ,H140941 ,H270788 ,H271663 ,H271954 ,H272187 ,H272370 ,H272826 ,H272990  ,H140132 ,H140239 ,H140759 ,H140819 ,H140879 ,H140942 ,H270794 ,H271664 ,H271961 ,H272188 ,H272372 ,H272827 ,H272993  ,H140133 ,H140240 ,H140760 ,H140820 ,H140881 ,H140943 ,H271041 ,H271669 ,H271964 ,H272195 ,H272377 ,H272828 ,H272996  ,H140134 ,H140700 ,H140761 ,H140821 ,H140882 ,H140944 ,H271066 ,H271678 ,H271972 ,H272197 ,H272380 ,H272834 ,H272999  ,H140135 ,H140701 ,H140762 ,H140822 ,H140883 ,H140945 ,H271105 ,H271681 ,H271973 ,H272202 ,H272381 ,H272837 ,H273003  ,H140136 ,H140702 ,H140763 ,H140823 ,H140884 ,H140947 ,H271157 ,H271691 ,H271974 ,H272203 ,H272388 ,H272841 ,H273004  ,H140137 ,H140703 ,H140764 ,H140824 ,H140885 ,H140948 ,H271158 ,H271693 ,H271975 ,H272204 ,H272394 ,H272842 ,H273006  ,H140138 ,H140704 ,H140765 ,H140825 ,H140886 ,H140949 ,H271159 ,H271711 ,H271976 ,H272209 ,H272397 ,H272846 ,H273011  ,H140139 ,H140705 ,H140766 ,H140826 ,H140887 ,H140950 ,H271167 ,H271712 ,H271993 ,H272216 ,H272401 ,H272847 ,H273016  ,H140140 ,H140706 ,H140767 ,H140827 ,H140888 ,H140951 ,H271194 ,H271713 ,H271994 ,H272219 ,H272405 ,H272848 ,H273026  ,H140141 ,H140707 ,H140768 ,H140828 ,H140889 ,H140952 ,H271214 ,H271714 ,H272000 ,H272220 ,H272407 ,H272849 ,H273027  ,H140142 ,H140708 ,H140769 ,H140829 ,H140890 ,H140953 ,H271227 ,H271720 ,H272001 ,H272223 ,H272410 ,H272854 ,H273029  ,H140143 ,H140709 ,H140770 ,H140830 ,H140891 ,H140956 ,H271242 ,H271724 ,H272003 ,H272226 ,H272412 ,H272856 ,H273030  ,H140144 ,H140710 ,H140771 ,H140831 ,H140892 ,H140957 ,H271258 ,H271729 ,H272009 ,H272231 ,H272413 ,H272857 ,H273031  ,H273032 ,H273133 ,H273197 ,H290501 ,H291030 ,H291094 ,H291158 ,H291220 ,H293306 ,H293369 ,H293432 ,H293494 ,H293558  ,H273035 ,H273134 ,H273198 ,H290503 ,H291031 ,H291095 ,H291159 ,H291221 ,H293307 ,H293370 ,H293433 ,H293495 ,H293559  ,H273036 ,H273135 ,H273199 ,H290504 ,H291032 ,H291096 ,H291160 ,H291222 ,H293308 ,H293371 ,H293434 ,H293496 ,H293560  ,H273039 ,H273136 ,H273200 ,H290505 ,H291034 ,H291097 ,H291161 ,H291223 ,H293309 ,H293372 ,H293435 ,H293497 ,H293561  ,H273040 ,H273137 ,H273201 ,H290508 ,H291035 ,H291098 ,H291162 ,H291224 ,H293310 ,H293373 ,H293436 ,H293498 ,H293562  ,H273041 ,H273138 ,H273202 ,H290509 ,H291036 ,H291099 ,H291163 ,H291225 ,H293311 ,H293374 ,H293437 ,H293499 ,H293563  ,H273042 ,H273139 ,H273203 ,H290510 ,H291037 ,H291101 ,H291164 ,H291226 ,H293312 ,H293375 ,H293438 ,H293500 ,H293564  ,H273048 ,H273140 ,H273204 ,H290511 ,H291038 ,H291102 ,H291165 ,H291227 ,H293313 ,H293376 ,H293439 ,H293501 ,H293565  ,H273049 ,H273141 ,H273205 ,H290512 ,H291039 ,H291103 ,H291166 ,H291228 ,H293314 ,H293377 ,H293440 ,H293502 ,H293566  ,H273052 ,H273142 ,H273206 ,H290517 ,H291040 ,H291104 ,H291167 ,H291229 ,H293315 ,H293378 ,H293441 ,H293503 ,H293567  ,H273053 ,H273143 ,H273208 ,H290519 ,H291041 ,H291105 ,H291168 ,H291230 ,H293316 ,H293379 ,H293442 ,H293504 ,H293568  ,H273055 ,H273144 ,H273209 ,H290520 ,H291042 ,H291106 ,H291169 ,H291231 ,H293317 ,H293380 ,H293443 ,H293505 ,H293569  ,H273056 ,H273145 ,H273210 ,H290530 ,H291043 ,H291107 ,H291170 ,H291232 ,H293318 ,H293381 ,H293444 ,H293506 ,H293570  ,H273057 ,H273146 ,H273547 ,H290533 ,H291044 ,H291108 ,H291171 ,H291233 ,H293319 ,H293382 ,H293445 ,H293507 ,H293571  ,H273063 ,H273147 ,H273711 ,H290538 ,H291045 ,H291109 ,H291172 ,H291234 ,H293320 ,H293383 ,H293446 ,H293508 ,H293572  ,H273064 ,H273148 ,H273929 ,H290540 ,H291046 ,H291111 ,H291173 ,H291235 ,H293321 ,H293384 ,H293447 ,H293509 ,H293573  ,H273065 ,H273149 ,H290186 ,H290541 ,H291047 ,H291112 ,H291174 ,H291236 ,H293323 ,H293385 ,H293448 ,H293510 ,H293574  ,H273066 ,H273150 ,H290192 ,H290547 ,H291048 ,H291113 ,H291175 ,H291237 ,H293324 ,H293386 ,H293449 ,H293511 ,H293575  ,H273072 ,H273151 ,H290201 ,H290548 ,H291049 ,H291114 ,H291176 ,H291238 ,H293325 ,H293387 ,H293450 ,H293512 ,H293576  ,H273075 ,H273152 ,H290208 ,H290549 ,H291050 ,H291115 ,H291177 ,H291239 ,H293326 ,H293388 ,H293451 ,H293513 ,H293577  ,H273077 ,H273153 ,H290222 ,H290550 ,H291051 ,H291116 ,H291178 ,H291240 ,H293327 ,H293389 ,H293452 ,H293514 ,H293578  ,H273080 ,H273155 ,H290224 ,H290551 ,H291052 ,H291117 ,H291179 ,H291241 ,H293328 ,H293390 ,H293453 ,H293515 ,H293579  ,H273082 ,H273156 ,H290233 ,H290552 ,H291053 ,H291118 ,H291180 ,H291242 ,H293329 ,H293391 ,H293454 ,H293516 ,H293581  ,H273083 ,H273157 ,H290241 ,H290553 ,H291054 ,H291119 ,H291181 ,H291243 ,H293330 ,H293392 ,H293455 ,H293517 ,H293583  ,H273084 ,H273158 ,H290243 ,H290554 ,H291055 ,H291120 ,H291182 ,H291244 ,H293331 ,H293393 ,H293456 ,H293518 ,H293584  ,H273086 ,H273159 ,H290248 ,H290555 ,H291056 ,H291121 ,H291183 ,H291245 ,H293332 ,H293394 ,H293457 ,H293519 ,H293585  ,H273088 ,H273160 ,H290249 ,H290556 ,H291057 ,H291122 ,H291184 ,H291246 ,H293333 ,H293395 ,H293458 ,H293520 ,H293586  ,H273089 ,H273162 ,H290256 ,H290557 ,H291059 ,H291123 ,H291185 ,H291247 ,H293334 ,H293396 ,H293459 ,H293521 ,H293587  ,H273092 ,H273163 ,H290262 ,H290558 ,H291060 ,H291124 ,H291186 ,H291248 ,H293335 ,H293397 ,H293460 ,H293522 ,H293588  ,H273093 ,H273164 ,H290272 ,H290559 ,H291061 ,H291125 ,H291187 ,H291249 ,H293336 ,H293398 ,H293461 ,H293523 ,H293589  ,H273100 ,H273165 ,H290274 ,H290560 ,H291062 ,H291126 ,H291188 ,H291250 ,H293337 ,H293399 ,H293462 ,H293524 ,H293590  ,H273101 ,H273166 ,H290278 ,H290561 ,H291063 ,H291127 ,H291189 ,H291251 ,H293338 ,H293401 ,H293463 ,H293525 ,H293591  ,H273102 ,H273167 ,H290282 ,H290600 ,H291064 ,H291128 ,H291190 ,H291252 ,H293339 ,H293402 ,H293464 ,H293527 ,H293592  ,H273103 ,H273168 ,H290287 ,H291001 ,H291065 ,H291129 ,H291191 ,H291253 ,H293340 ,H293403 ,H293465 ,H293528 ,H293593  ,H273104 ,H273169 ,H290295 ,H291002 ,H291066 ,H291130 ,H291192 ,H291254 ,H293341 ,H293404 ,H293466 ,H293529 ,H293594  ,H273105 ,H273170 ,H290304 ,H291003 ,H291067 ,H291131 ,H291193 ,H291255 ,H293342 ,H293405 ,H293467 ,H293530 ,H293595  ,H273106 ,H273171 ,H290308 ,H291004 ,H291068 ,H291132 ,H291194 ,H291256 ,H293343 ,H293406 ,H293468 ,H293531 ,H293596  ,H273107 ,H273172 ,H290313 ,H291005 ,H291069 ,H291133 ,H291195 ,H291257 ,H293344 ,H293407 ,H293469 ,H293532 ,H293597  ,H273108 ,H273173 ,H290317 ,H291006 ,H291070 ,H291134 ,H291196 ,H291258 ,H293345 ,H293408 ,H293470 ,H293533 ,H293598  ,H273109 ,H273174 ,H290321 ,H291007 ,H291071 ,H291135 ,H291197 ,H291259 ,H293346 ,H293409 ,H293471 ,H293534 ,H293599  ,H273110 ,H273175 ,H290326 ,H291008 ,H291072 ,H291136 ,H291198 ,H291260 ,H293347 ,H293410 ,H293472 ,H293535 ,H293600  ,H273111 ,H273176 ,H290341 ,H291009 ,H291073 ,H291137 ,H291199 ,H291261 ,H293348 ,H293411 ,H293473 ,H293536 ,H293601  ,H273112 ,H273177 ,H290352 ,H291010 ,H291074 ,H291138 ,H291200 ,H291262 ,H293349 ,H293412 ,H293474 ,H293537 ,H293602  ,H273113 ,H273178 ,H290358 ,H291011 ,H291075 ,H291139 ,H291201 ,H291263 ,H293350 ,H293413 ,H293475 ,H293538 ,H293603  ,H273114 ,H273179 ,H290362 ,H291012 ,H291076 ,H291140 ,H291202 ,H291264 ,H293351 ,H293414 ,H293476 ,H293539 ,H293604     ,H273115 ,H273180 ,H290371 ,H291013 ,H291077 ,H291141 ,H291203 ,H291265 ,H293352 ,H293415 ,H293477 ,H293540 ,H293605  ,H273116 ,H273181 ,H290372 ,H291014 ,H291078 ,H291142 ,H291204 ,H291266 ,H293353 ,H293416 ,H293478 ,H293541 ,H293606  ,H273117 ,H273182 ,H290376 ,H291015 ,H291079 ,H291143 ,H291205 ,H291267 ,H293354 ,H293417 ,H293479 ,H293542 ,H293607  ,H273118 ,H273183 ,H290379 ,H291016 ,H291080 ,H291144 ,H291206 ,H291268 ,H293355 ,H293418 ,H293480 ,H293543 ,H293608  ,H273119 ,H273184 ,H290381 ,H291017 ,H291081 ,H291145 ,H291207 ,H291269 ,H293356 ,H293419 ,H293481 ,H293544 ,H293609  ,H273120 ,H273185 ,H290386 ,H291018 ,H291082 ,H291146 ,H291208 ,H291270 ,H293357 ,H293420 ,H293482 ,H293545 ,H293610  ,H273121 ,H273186 ,H290392 ,H291019 ,H291083 ,H291147 ,H291209 ,H291271 ,H293358 ,H293421 ,H293483 ,H293546 ,H293611  ,H273122 ,H273187 ,H290397 ,H291020 ,H291084 ,H291148 ,H291210 ,H291272 ,H293359 ,H293422 ,H293484 ,H293548 ,H293612  ,H273123 ,H273188 ,H290399 ,H291021 ,H291085 ,H291149 ,H291211 ,H291273 ,H293360 ,H293423 ,H293485 ,H293549 ,H293613  ,H273124 ,H273189 ,H290400 ,H291022 ,H291086 ,H291150 ,H291212 ,H293009 ,H293361 ,H293424 ,H293486 ,H293550 ,H293614  ,H273125 ,H273190 ,H290401 ,H291023 ,H291087 ,H291151 ,H291213 ,H293207 ,H293362 ,H293425 ,H293487 ,H293551 ,H293615  ,H273126 ,H273191 ,H290402 ,H291024 ,H291088 ,H291152 ,H291214 ,H293300 ,H293363 ,H293426 ,H293488 ,H293552 ,H293616  ,H273127 ,H273192 ,H290403 ,H291025 ,H291089 ,H291153 ,H291215 ,H293301 ,H293364 ,H293427 ,H293489 ,H293553 ,H293617  ,H273128 ,H273193 ,H290405 ,H291026 ,H291090 ,H291154 ,H291216 ,H293302 ,H293365 ,H293428 ,H293490 ,H293554 ,H293618  ,H273130 ,H273194 ,H290414 ,H291027 ,H291091 ,H291155 ,H291217 ,H293303 ,H293366 ,H293429 ,H293491 ,H293555 ,H293619  ,H273131 ,H273195 ,H290422 ,H291028 ,H291092 ,H291156 ,H291218 ,H293304 ,H293367 ,H293430 ,H293492 ,H293556 ,H293620  ,H273132 ,H273196 ,H290423 ,H291029 ,H291093 ,H291157 ,H291219 ,H293305 ,H293368 ,H293431 ,H293493 ,H293557 ,H293621  ,H293622 ,H293686 ,H293749 ,H293812 ,H293875 ,H293938 ,H294002 ,H294065 ,H294129 ,H294192 ,H294254 ,H294317 ,H294381  ,H293623 ,H293687 ,H293750 ,H293813 ,H293876 ,H293940 ,H294003 ,H294066 ,H294130 ,H294193 ,H294255 ,H294318 ,H294382  ,H293624 ,H293688 ,H293751 ,H293814 ,H293877 ,H293941 ,H294004 ,H294067 ,H294131 ,H294194 ,H294256 ,H294319 ,H294383  ,H293625 ,H293689 ,H293752 ,H293815 ,H293878 ,H293942 ,H294005 ,H294068 ,H294132 ,H294195 ,H294257 ,H294320 ,H294384  ,H293626 ,H293690 ,H293753 ,H293816 ,H293879 ,H293943 ,H294006 ,H294069 ,H294133 ,H294196 ,H294258 ,H294321 ,H294385  ,H293627 ,H293691 ,H293754 ,H293817 ,H293880 ,H293944 ,H294007 ,H294070 ,H294134 ,H294197 ,H294259 ,H294322 ,H294386  ,H293628 ,H293692 ,H293755 ,H293818 ,H293881 ,H293945 ,H294008 ,H294071 ,H294135 ,H294198 ,H294260 ,H294323 ,H294387  ,H293629 ,H293693 ,H293756 ,H293819 ,H293882 ,H293946 ,H294009 ,H294072 ,H294136 ,H294199 ,H294261 ,H294324 ,H294388  ,H293630 ,H293694 ,H293758 ,H293820 ,H293883 ,H293947 ,H294010 ,H294073 ,H294137 ,H294200 ,H294262 ,H294325 ,H294389  ,H293631 ,H293695 ,H293759 ,H293821 ,H293884 ,H293948 ,H294011 ,H294074 ,H294139 ,H294201 ,H294263 ,H294326 ,H294390  ,H293632 ,H293696 ,H293760 ,H293822 ,H293885 ,H293949 ,H294012 ,H294075 ,H294140 ,H294202 ,H294264 ,H294328 ,H294391  ,H293633 ,H293697 ,H293761 ,H293823 ,H293886 ,H293950 ,H294013 ,H294076 ,H294141 ,H294203 ,H294265 ,H294329 ,H294392  ,H293634 ,H293698 ,H293762 ,H293824 ,H293887 ,H293951 ,H294014 ,H294077 ,H294142 ,H294204 ,H294266 ,H294330 ,H294393  ,H293635 ,H293699 ,H293763 ,H293825 ,H293888 ,H293952 ,H294015 ,H294078 ,H294143 ,H294205 ,H294267 ,H294331 ,H294394  ,H293636 ,H293700 ,H293764 ,H293826 ,H293889 ,H293953 ,H294016 ,H294079 ,H294144 ,H294206 ,H294268 ,H294332 ,H294395  ,H293637 ,H293701 ,H293765 ,H293827 ,H293890 ,H293954 ,H294017 ,H294080 ,H294145 ,H294207 ,H294269 ,H294333 ,H294396  ,H293638 ,H293702 ,H293766 ,H293828 ,H293891 ,H293955 ,H294018 ,H294081 ,H294146 ,H294208 ,H294270 ,H294334 ,H294397  ,H293639 ,H293703 ,H293767 ,H293829 ,H293892 ,H293956 ,H294020 ,H294083 ,H294147 ,H294209 ,H294271 ,H294335 ,H294398  ,H293640 ,H293704 ,H293768 ,H293830 ,H293893 ,H293957 ,H294021 ,H294084 ,H294148 ,H294210 ,H294272 ,H294336 ,H294399  ,H293641 ,H293705 ,H293769 ,H293831 ,H293894 ,H293958 ,H294022 ,H294085 ,H294149 ,H294211 ,H294273 ,H294337 ,H294400  ,H293642 ,H293706 ,H293770 ,H293832 ,H293895 ,H293959 ,H294023 ,H294086 ,H294150 ,H294212 ,H294274 ,H294338 ,H294401  ,H293643 ,H293707 ,H293771 ,H293833 ,H293896 ,H293960 ,H294024 ,H294087 ,H294151 ,H294213 ,H294275 ,H294339 ,H294402  ,H293644 ,H293708 ,H293772 ,H293834 ,H293897 ,H293961 ,H294025 ,H294088 ,H294152 ,H294214 ,H294276 ,H294340 ,H294403  ,H293645 ,H293709 ,H293773 ,H293835 ,H293898 ,H293962 ,H294026 ,H294089 ,H294153 ,H294215 ,H294277 ,H294341 ,H294404  ,H293646 ,H293710 ,H293774 ,H293836 ,H293899 ,H293963 ,H294027 ,H294090 ,H294154 ,H294216 ,H294278 ,H294342 ,H294405  ,H293648 ,H293712 ,H293775 ,H293837 ,H293900 ,H293964 ,H294028 ,H294091 ,H294155 ,H294217 ,H294279 ,H294343 ,H294406  ,H293649 ,H293713 ,H293776 ,H293838 ,H293901 ,H293965 ,H294029 ,H294092 ,H294156 ,H294218 ,H294280 ,H294345 ,H294407  ,H293650 ,H293714 ,H293777 ,H293839 ,H293902 ,H293966 ,H294030 ,H294093 ,H294157 ,H294219 ,H294281 ,H294346 ,H294408  ,H293651 ,H293715 ,H293778 ,H293840 ,H293903 ,H293967 ,H294031 ,H294094 ,H294158 ,H294220 ,H294283 ,H294347 ,H294409  ,H293652 ,H293716 ,H293779 ,H293841 ,H293904 ,H293968 ,H294032 ,H294095 ,H294159 ,H294221 ,H294284 ,H294348 ,H294410  ,H293653 ,H293717 ,H293780 ,H293842 ,H293905 ,H293969 ,H294033 ,H294097 ,H294160 ,H294222 ,H294285 ,H294349 ,H294411  ,H293654 ,H293718 ,H293781 ,H293843 ,H293906 ,H293970 ,H294034 ,H294098 ,H294161 ,H294223 ,H294286 ,H294350 ,H294412  ,H293655 ,H293719 ,H293782 ,H293844 ,H293907 ,H293971 ,H294035 ,H294099 ,H294162 ,H294224 ,H294287 ,H294351 ,H294413  ,H293656 ,H293720 ,H293783 ,H293845 ,H293908 ,H293972 ,H294036 ,H294100 ,H294163 ,H294225 ,H294288 ,H294352 ,H294414  ,H293657 ,H293721 ,H293784 ,H293846 ,H293909 ,H293974 ,H294037 ,H294101 ,H294164 ,H294226 ,H294289 ,H294353 ,H294415  ,H293658 ,H293722 ,H293785 ,H293847 ,H293910 ,H293975 ,H294038 ,H294102 ,H294165 ,H294227 ,H294290 ,H294354 ,H294416  ,H293659 ,H293723 ,H293786 ,H293848 ,H293911 ,H293976 ,H294039 ,H294103 ,H294166 ,H294228 ,H294291 ,H294355 ,H294417  ,H293660 ,H293724 ,H293787 ,H293849 ,H293912 ,H293977 ,H294040 ,H294104 ,H294167 ,H294229 ,H294292 ,H294356 ,H294418  ,H293661 ,H293725 ,H293788 ,H293850 ,H293913 ,H293978 ,H294041 ,H294105 ,H294168 ,H294230 ,H294293 ,H294357 ,H294419  ,H293662 ,H293726 ,H293789 ,H293851 ,H293914 ,H293979 ,H294042 ,H294106 ,H294169 ,H294231 ,H294294 ,H294358 ,H294420  ,H293663 ,H293727 ,H293790 ,H293852 ,H293915 ,H293980 ,H294043 ,H294107 ,H294170 ,H294232 ,H294295 ,H294359 ,H294421  ,H293664 ,H293728 ,H293791 ,H293854 ,H293916 ,H293981 ,H294044 ,H294108 ,H294171 ,H294233 ,H294296 ,H294360 ,H294422  ,H293665 ,H293729 ,H293792 ,H293855 ,H293917 ,H293982 ,H294045 ,H294109 ,H294172 ,H294234 ,H294297 ,H294361 ,H294423  ,H293666 ,H293730 ,H293793 ,H293856 ,H293918 ,H293983 ,H294046 ,H294110 ,H294173 ,H294235 ,H294298 ,H294362 ,H294424  ,H293667 ,H293731 ,H293794 ,H293857 ,H293919 ,H293984 ,H294047 ,H294111 ,H294174 ,H294236 ,H294299 ,H294363 ,H294425  ,H293668 ,H293732 ,H293795 ,H293858 ,H293920 ,H293985 ,H294048 ,H294112 ,H294175 ,H294237 ,H294300 ,H294364 ,H294426  ,H293669 ,H293733 ,H293796 ,H293859 ,H293921 ,H293986 ,H294049 ,H294113 ,H294176 ,H294238 ,H294301 ,H294365 ,H294427  ,H293670 ,H293734 ,H293797 ,H293860 ,H293922 ,H293987 ,H294050 ,H294114 ,H294177 ,H294239 ,H294302 ,H294366 ,H294428  ,H293671 ,H293735 ,H293798 ,H293861 ,H293923 ,H293988 ,H294051 ,H294115 ,H294178 ,H294240 ,H294303 ,H294367 ,H294429  ,H293672 ,H293736 ,H293799 ,H293862 ,H293924 ,H293989 ,H294052 ,H294116 ,H294179 ,H294241 ,H294304 ,H294368 ,H294430  ,H293673 ,H293737 ,H293800 ,H293863 ,H293925 ,H293990 ,H294053 ,H294117 ,H294180 ,H294242 ,H294305 ,H294369 ,H294431     ,H293674 ,H293738 ,H293801 ,H293864 ,H293926 ,H293991 ,H294054 ,H294118 ,H294181 ,H294243 ,H294306 ,H294370 ,H294432  ,H293675 ,H293739 ,H293802 ,H293865 ,H293927 ,H293992 ,H294055 ,H294119 ,H294182 ,H294244 ,H294307 ,H294371 ,H294433  ,H293676 ,H293740 ,H293803 ,H293866 ,H293928 ,H293993 ,H294056 ,H294120 ,H294183 ,H294245 ,H294308 ,H294372 ,H294434  ,H293677 ,H293741 ,H293804 ,H293867 ,H293929 ,H293994 ,H294057 ,H294121 ,H294184 ,H294246 ,H294309 ,H294373 ,H294435  ,H293678 ,H293742 ,H293805 ,H293868 ,H293930 ,H293995 ,H294058 ,H294122 ,H294185 ,H294247 ,H294310 ,H294374 ,H294436  ,H293679 ,H293743 ,H293806 ,H293869 ,H293931 ,H293996 ,H294059 ,H294123 ,H294186 ,H294248 ,H294311 ,H294375 ,H294437  ,H293681 ,H293744 ,H293807 ,H293870 ,H293933 ,H293997 ,H294060 ,H294124 ,H294187 ,H294249 ,H294312 ,H294376 ,H294438  ,H293682 ,H293745 ,H293808 ,H293871 ,H293934 ,H293998 ,H294061 ,H294125 ,H294188 ,H294250 ,H294313 ,H294377 ,H294439  ,H293683 ,H293746 ,H293809 ,H293872 ,H293935 ,H293999 ,H294062 ,H294126 ,H294189 ,H294251 ,H294314 ,H294378 ,H294440  ,H293684 ,H293747 ,H293810 ,H293873 ,H293936 ,H294000 ,H294063 ,H294127 ,H294190 ,H294252 ,H294315 ,H294379 ,H294442  ,H293685 ,H293748 ,H293811 ,H293874 ,H293937 ,H294001 ,H294064 ,H294128 ,H294191 ,H294253 ,H294316 ,H294380 ,H294443  ,H294444 ,H294508 ,H294577 ,H294640 ,H294702 ,H294768 ,H294832 ,H294897 ,H294963 ,H295030 ,H295097 ,H295170 ,H295275  ,H294445 ,H294509 ,H294578 ,H294641 ,H294704 ,H294769 ,H294833 ,H294898 ,H294965 ,H295031 ,H295099 ,H295171 ,H295276  ,H294446 ,H294510 ,H294579 ,H294642 ,H294705 ,H294770 ,H294834 ,H294899 ,H294966 ,H295032 ,H295100 ,H295172 ,H295277  ,H294447 ,H294511 ,H294580 ,H294643 ,H294706 ,H294771 ,H294835 ,H294900 ,H294967 ,H295033 ,H295101 ,H295173 ,H295279  ,H294448 ,H294512 ,H294581 ,H294644 ,H294707 ,H294772 ,H294836 ,H294901 ,H294969 ,H295034 ,H295102 ,H295174 ,H295281  ,H294449 ,H294513 ,H294582 ,H294645 ,H294708 ,H294773 ,H294837 ,H294902 ,H294970 ,H295035 ,H295103 ,H295176 ,H295282  ,H294450 ,H294514 ,H294583 ,H294646 ,H294709 ,H294774 ,H294838 ,H294903 ,H294971 ,H295036 ,H295105 ,H295177 ,H295284  ,H294451 ,H294515 ,H294584 ,H294647 ,H294710 ,H294775 ,H294839 ,H294904 ,H294972 ,H295037 ,H295106 ,H295178 ,H295287  ,H294452 ,H294516 ,H294585 ,H294648 ,H294711 ,H294776 ,H294840 ,H294905 ,H294974 ,H295038 ,H295107 ,H295179 ,H295290  ,H294454 ,H294517 ,H294586 ,H294649 ,H294712 ,H294777 ,H294841 ,H294906 ,H294975 ,H295039 ,H295108 ,H295180 ,H295291  ,H294455 ,H294518 ,H294587 ,H294650 ,H294713 ,H294778 ,H294842 ,H294907 ,H294976 ,H295040 ,H295109 ,H295181 ,H295299  ,H294457 ,H294519 ,H294588 ,H294651 ,H294714 ,H294779 ,H294843 ,H294908 ,H294977 ,H295041 ,H295110 ,H295182 ,H295300  ,H294458 ,H294520 ,H294589 ,H294652 ,H294715 ,H294780 ,H294844 ,H294910 ,H294978 ,H295042 ,H295111 ,H295183 ,H295301  ,H294459 ,H294521 ,H294590 ,H294653 ,H294716 ,H294781 ,H294845 ,H294911 ,H294979 ,H295043 ,H295112 ,H295184  ,H294460 ,H294522 ,H294591 ,H294654 ,H294717 ,H294782 ,H294846 ,H294912 ,H294980 ,H295044 ,H295114 ,H295185  ,H294461 ,H294523 ,H294592 ,H294655 ,H294718 ,H294783 ,H294847 ,H294914 ,H294981 ,H295045 ,H295116 ,H295186  ,H294462 ,H294524 ,H294593 ,H294656 ,H294719 ,H294784 ,H294848 ,H294915 ,H294982 ,H295046 ,H295117 ,H295188  ,H294463 ,H294525 ,H294594 ,H294657 ,H294720 ,H294785 ,H294850 ,H294916 ,H294983 ,H295047 ,H295118 ,H295193  ,H294464 ,H294526 ,H294595 ,H294658 ,H294723 ,H294786 ,H294851 ,H294917 ,H294984 ,H295048 ,H295119 ,H295195  ,H294465 ,H294527 ,H294596 ,H294659 ,H294724 ,H294787 ,H294853 ,H294918 ,H294986 ,H295049 ,H295120 ,H295196  ,H294466 ,H294528 ,H294597 ,H294660 ,H294726 ,H294788 ,H294854 ,H294919 ,H294987 ,H295050 ,H295121 ,H295199  ,H294467 ,H294529 ,H294598 ,H294661 ,H294727 ,H294789 ,H294855 ,H294920 ,H294988 ,H295051 ,H295122 ,H295201  ,H294468 ,H294530 ,H294599 ,H294662 ,H294728 ,H294790 ,H294856 ,H294921 ,H294989 ,H295053 ,H295123 ,H295202  ,H294469 ,H294531 ,H294600 ,H294663 ,H294729 ,H294791 ,H294857 ,H294922 ,H294990 ,H295054 ,H295124 ,H295203  ,H294470 ,H294532 ,H294601 ,H294664 ,H294730 ,H294792 ,H294858 ,H294923 ,H294991 ,H295056 ,H295125 ,H295206  ,H294471 ,H294533 ,H294602 ,H294665 ,H294731 ,H294793 ,H294859 ,H294924 ,H294992 ,H295057 ,H295126 ,H295207  ,H294472 ,H294534 ,H294603 ,H294666 ,H294732 ,H294794 ,H294860 ,H294925 ,H294993 ,H295058 ,H295127 ,H295208  ,H294473 ,H294535 ,H294604 ,H294667 ,H294733 ,H294795 ,H294861 ,H294926 ,H294995 ,H295059 ,H295128 ,H295209  ,H294474 ,H294536 ,H294605 ,H294668 ,H294734 ,H294796 ,H294862 ,H294927 ,H294996 ,H295060 ,H295129 ,H295210  ,H294475 ,H294537 ,H294606 ,H294669 ,H294735 ,H294797 ,H294863 ,H294928 ,H294997 ,H295061 ,H295130 ,H295211  ,H294476 ,H294538 ,H294607 ,H294670 ,H294736 ,H294798 ,H294864 ,H294929 ,H294998 ,H295062 ,H295131 ,H295212  ,H294477 ,H294539 ,H294608 ,H294671 ,H294737 ,H294799 ,H294865 ,H294930 ,H294999 ,H295063 ,H295132 ,H295213  ,H294478 ,H294540 ,H294610 ,H294672 ,H294738 ,H294800 ,H294866 ,H294931 ,H295000 ,H295064 ,H295133 ,H295214  ,H294479 ,H294541 ,H294611 ,H294673 ,H294739 ,H294801 ,H294867 ,H294932 ,H295001 ,H295065 ,H295134 ,H295216  ,H294480 ,H294542 ,H294612 ,H294674 ,H294740 ,H294802 ,H294868 ,H294933 ,H295002 ,H295066 ,H295135 ,H295217  ,H294481 ,H294543 ,H294613 ,H294675 ,H294741 ,H294803 ,H294869 ,H294934 ,H295003 ,H295067 ,H295136 ,H295221  ,H294482 ,H294544 ,H294614 ,H294676 ,H294742 ,H294804 ,H294870 ,H294935 ,H295004 ,H295068 ,H295138 ,H295223  ,H294483 ,H294545 ,H294615 ,H294677 ,H294743 ,H294806 ,H294871 ,H294936 ,H295005 ,H295069 ,H295139 ,H295224  ,H294484 ,H294546 ,H294616 ,H294678 ,H294744 ,H294807 ,H294872 ,H294937 ,H295006 ,H295070 ,H295140 ,H295225  ,H294485 ,H294547 ,H294617 ,H294679 ,H294745 ,H294808 ,H294874 ,H294938 ,H295007 ,H295071 ,H295141 ,H295226  ,H294486 ,H294548 ,H294618 ,H294680 ,H294746 ,H294809 ,H294875 ,H294940 ,H295008 ,H295072 ,H295142 ,H295227  ,H294487 ,H294549 ,H294619 ,H294681 ,H294747 ,H294810 ,H294876 ,H294941 ,H295009 ,H295073 ,H295143 ,H295228  ,H294488 ,H294550 ,H294620 ,H294682 ,H294748 ,H294811 ,H294877 ,H294942 ,H295010 ,H295074 ,H295144 ,H295229  ,H294489 ,H294551 ,H294621 ,H294683 ,H294749 ,H294812 ,H294878 ,H294943 ,H295011 ,H295075 ,H295145 ,H295231  ,H294490 ,H294552 ,H294622 ,H294684 ,H294750 ,H294813 ,H294879 ,H294945 ,H295012 ,H295076 ,H295146 ,H295235  ,H294491 ,H294553 ,H294623 ,H294685 ,H294751 ,H294814 ,H294880 ,H294946 ,H295013 ,H295077 ,H295147 ,H295236  ,H294492 ,H294554 ,H294624 ,H294686 ,H294752 ,H294815 ,H294881 ,H294947 ,H295014 ,H295078 ,H295148 ,H295238  ,H294493 ,H294555 ,H294625 ,H294687 ,H294753 ,H294816 ,H294882 ,H294948 ,H295015 ,H295080 ,H295149 ,H295239  ,H294494 ,H294556 ,H294626 ,H294688 ,H294754 ,H294817 ,H294883 ,H294949 ,H295016 ,H295081 ,H295150 ,H295240  ,H294495 ,H294557 ,H294627 ,H294689 ,H294755 ,H294818 ,H294884 ,H294950 ,H295017 ,H295082 ,H295151 ,H295241  ,H294496 ,H294564 ,H294628 ,H294690 ,H294756 ,H294820 ,H294885 ,H294951 ,H295018 ,H295083 ,H295152 ,H295242  ,H294497 ,H294565 ,H294629 ,H294691 ,H294757 ,H294821 ,H294886 ,H294952 ,H295019 ,H295084 ,H295154 ,H295244  ,H294498 ,H294567 ,H294630 ,H294692 ,H294758 ,H294822 ,H294887 ,H294953 ,H295020 ,H295085 ,H295155 ,H295245  ,H294499 ,H294568 ,H294631 ,H294693 ,H294759 ,H294823 ,H294888 ,H294954 ,H295021 ,H295086 ,H295156 ,H295246  ,H294500 ,H294569 ,H294632 ,H294694 ,H294760 ,H294824 ,H294889 ,H294955 ,H295022 ,H295087 ,H295157 ,H295247  ,H294501 ,H294570 ,H294633 ,H294695 ,H294761 ,H294825 ,H294890 ,H294956 ,H295023 ,H295089 ,H295158 ,H295248  ,H294502 ,H294571 ,H294634 ,H294696 ,H294762 ,H294826 ,H294891 ,H294957 ,H295024 ,H295090 ,H295159 ,H295249      ,H294503 ,H294572 ,H294635 ,H294697 ,H294763 ,H294827 ,H294892 ,H294958 ,H295025 ,H295091 ,H295160 ,H295250  ,H294504 ,H294573 ,H294636 ,H294698 ,H294764 ,H294828 ,H294893 ,H294959 ,H295026 ,H295093 ,H295161 ,H295252  ,H294505 ,H294574 ,H294637 ,H294699 ,H294765 ,H294829 ,H294894 ,H294960 ,H295027 ,H295094 ,H295162 ,H295254  ,H294506 ,H294575 ,H294638 ,H294700 ,H294766 ,H294830 ,H294895 ,H294961 ,H295028 ,H295095 ,H295163 ,H295255  ,H294507 ,H294576 ,H294639 ,H294701 ,H294767 ,H294831 ,H294896 ,H294962 ,H295029 ,H295096 ,H295169 ,H295265

510(k) numbers

["K101751"]

PMA numbers

not on file

Product code

IYE

Firm FEI

2916710

Firm city

Palo Alto

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy