FDAFDA · Food and drugs·Recall number Z-1502-2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
Published April 30, 2014 · Recall initiated: March 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc.
- Distributor
- Worldwide Distribution.
- Lot
- Model H08: Code numbers: H080002 H080065 H080126 H080187 H080251 H080314 H080378 H080441 H080503 H080607 H080672 H080749 H080944 H080003 H080066 H080127 H080188 H080252 H080315 H080379 H080442 H080504 H080608 H080673 H080753 H080947 H080004 H080068 H080128 H080189 H080254 H080316 H080380 H080443 H080506 H080609 H080674 H080754 H080948 HOSOOOS H080069 H080129 H080190 H0802SS H080317 H080381 H080444 H080507 H080610 H080675 H0807SS H080950 H080006 H080071 H080130 H080191 H080256 H080318 H080382 H080445 H080508 H080611 H080676 H080756 H080960 H080008 H080072 H080131 H080192 H080257 H080319 H080383 H080446 H080509 H080612 H080677 H080759 H080961 H080009 H080073 H080132 H080193 H080258 H080320 H080384 H080447 HOSOSlO H080613 H080678 H080760 H080962 H080010 H080074 H080133 H080194 H080259 H080321 H08038S H080448 H080511 H080614 H080679 H080761 H080969 H080011 H080075 H080134 H080195 H080260 H080322 H080386 H080449 HOSOS12 H080615 H080680 H080762 H080970 H080012 H080076 H080136 H080196 H080261 H080324 H080387 H080450 H080513 H080616 H080683 H080763 H080971 H080013 H080077 H080137 H080197 H080262 H080325 H080389 H080451 H080514 H080617 H080684 H080764 H080989 H080014 H080078 H080138 H080198 H080263 H080326 H080391 H080452 H08051S H080618 H080685 H080766 H080991 H080016 H080079 H080139 H080199 H080264 H080327 H080392 H080453 H080516 H080619 H080686 H080768 H080997 H080017 HOSOOSO H080141 H080200 H080266 H080328 H080393 H080454 H080517 H080620 H080687 H080772 H081001 H080018 HOSOOSl H080142 H080202 H080267 H080329 H080394 H080455 H080518 H080621 H080688 H080773 H081004 H080019 H080082 H080143 H080203 H080268 H080330 H080395 H080456 H080519 H080622 H080689 H080774 H081005 H080020 H080083 H080144 H080204 H080269 H080331 H080396 H080457 H080520 H080623 H080690 H080775 H081006 H080021 H080084 H080145 H080205 H080270 H080332 H080397 H080458 H080521 H080624 H080691 H080778 H081007 H080022 H080085 H080147 H080206 H080271 H080333 H080398 H080459 H080522 H080625 H080692 H080783 H081009 H080024 H080086 H080148 H080207 H080272 H080334 H080399 H080460 H080523 H080626 H080693 H080786 H081017 H08002S H080087 H080149 H080208 H080273 H080335 H080400 H080461 H080524 H080627 H080695 H080788 H081019 H080026 H080088 H080150 H080209 H080274 H080336 H080401 H080462 H080525 H080628 H080696 H080791 H081020 H080027 H080089 H080151 H080210 H080275 H080337 H080402 H080463 H080526 H080629 H080697 H080798 H081021 H080028 H080090 H080152 H080211 H080276 H080338 H080403 H080464 H080527 H080630 H080698 H080800 H081023 H080029 H080091 H080153 H080212 H080277 H080339 H080404 H080465 H080528 H080631 H080699 H080801 H08102S H080030 H080092 H080154 H080213 H080278 H080340 H080405 H080466 H080529 H080632 H080700 H080805 H081026 H080031 H080093 H080155 H080214 H080279 H080341 H080407 H080467 H080530 H080633 H080701 H080812 H081027 H080032 H080094 H080156 H080215 H080280 H080342 H080408 H080468 H080531 H080634 H080702 H080836 H081031 H080033 H080095 H080157 H080216 H080281 H080344 H080409 H080469 H080532 H080635 H080703 H080840 H081034 H080034 H080096 H080158 H080217 H080282 H080345 H080410 H080470 H080534 H080636 H080706 H080852 H081035 H080035 H080097 H080159 H080218 H080283 H080346 H080411 H080471 H080535 H080637 H080707 H080853 H081037 H080036 H080098 H080160 H080219 H080286 H080348 H080412 H080472 H080536 H080641 H080708 H080857 H081038 H080037 H080099 H080161 H080220 H080287 H080349 H080413 H080473 H080537 H080642 H080709 H080859 H081042 H080038 H080100 H080162 H080221 H080288 H080350 H080414 H080474 H080538 H080643 H080710 H080860 H081043 H080039 H080101 H080163 H080222 H080289 H080351 H080415 H080476 H080539 H080644 H080711 H080861 H081044 H080040 H080102 H080164 H080224 H080290 H080352 H080416 H080478 H080540 H080645 H080712 H080864 H081045 H080041 H080103 H080165 H080225 H080291 H080353 H080417 H080479 H080541 H080646 H080713 H080865 H081046 H080042 H080104 H080166 H080226 H080292 H080354 H080418 H080480 H080542 H080647 H080714
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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