Events

Rappel de Device Recall Varian Trilogy System with RapidArc

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Varian Medical Systems Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56774
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0821-2011
  • Date de mise en oeuvre de l'événement
    2010-07-20
  • Date de publication de l'événement
    2010-12-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94517
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Accelerator, linear, medical - Product Code IYE
  • Cause
    The system may deliver an inaccurate dose that does not match the treatment plan. as a result of a system configuration problem, the vmat (volumetric modulated arc therapy) plans may be delivered as dynamic arc therapy plans. if this occurs, the vmat plan will not be recognized. this issue affects trilogy machines with the rapid arc treatment delivery option.
  • Action
    Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display "RapidArc" or "VMAT" under Treatment Type during dose delivery, discontinue use of the device and call Varian service. Varian Service Help Desk can be contacted at 1-888-827-4265.

Device

Device Recall Varian Trilogy System with RapidArc
  • Modèle / numéro de série
    H140025,H140753,H140845,H140896,H272157 ,H272963 ,H291040 ,H291187 ,H293443 ,H293691,H140038 ,H140769,H140846 ,H140901 ,H272158 ,H272981,H291048,H291190 ,H293447 ,H293696,H140045 ,H140772 ,H140848 ,H140902 ,H272165 ,H272982,H291050 ,H291206 ,H293475 ,H293700,H140047 ,H140773,H140849 ,H140904,H272178,H272985 ,H291051,H291226 ,H293496 ,H293709  ,H140078 ,H140777 ,H140850 ,H140906 ,H272187 ,H273049 ,H291053 ,H291230 ,H293507 ,H293725  ,H140092 ,H140780 ,H140851 ,H182012 ,H272188 ,H273065 ,H291060 ,H291234 ,H293519 ,H293726  ,H140096 ,H140781 ,H140853 ,H271167 ,H272216 ,H273162 ,H291067 ,H291242 ,H293538 ,H293727  ,H140097 ,H140783 ,H140854 ,H271370 ,H272220 ,H273170 ,H291072 ,H291247 ,H293541 ,H293728  ,H140122 ,H140787 ,H140855 ,H271378 ,H272231 ,H273202 ,H291081 ,H291248 ,H293560 ,H293736  ,H140124 ,H140790 ,H140856 ,H271385 ,H272309 ,H273203 ,H291084 ,H291251 ,H293565 ,H293737  ,H140125 ,H140794 ,H140857 ,H271531 ,H272310 ,H290278 ,H291088 ,H291253 ,H293577 ,H293749  ,H140144 ,H140795 ,H140858 ,H271588 ,H272325 ,H290282 ,H291096 ,H291254 ,H293581 ,H293769  ,H140146 ,H140797 ,H140863 ,H271607 ,H272360 ,H290362 ,H291099 ,H291262 ,H293592 ,H293773  ,H140148 ,H140799 ,H140864 ,H271618 ,H272377 ,H290399 ,H291107 ,H291270 ,H293596 ,H293774  ,H140201 ,H140800 ,H140865 ,H271662 ,H272401 ,H290400 ,H291115 ,H291271 ,H293611 ,H293775  ,H140202 ,H140801 ,H140866 ,H271663 ,H272426 ,H290402 ,H291116 ,H291272 ,H293624 ,H293778  ,H140206 ,H140808 ,H140867 ,H271729 ,H272427 ,H290501 ,H291117 ,H293312 ,H293627 ,H293779  ,H140214 ,H140812 ,H140868 ,H271785 ,H272440 ,H290503 ,H291118 ,H293325 ,H293632 ,H293780  ,H140216 ,H140816 ,H140869 ,H271825 ,H272456 ,H290510 ,H291119 ,H293327 ,H293636 ,H293781  ,H140218 ,H140817 ,H140871 ,H271890 ,H272473 ,H290512 ,H291124 ,H293335 ,H293638 ,H293790  ,H140222 ,H140818 ,H140874 ,H271906 ,H272491 ,H290519 ,H291133 ,H293342 ,H293642 ,H293802  ,H140223 ,H140819 ,H140876 ,H271926 ,H272497 ,H291007 ,H291136 ,H293353 ,H293644 ,H293804  ,H140224 ,H140820 ,H140877 ,H271941 ,H272500 ,H291008 ,H291138 ,H293361 ,H293646 ,H293805  ,H140233 ,H140824 ,H140881 ,H271951 ,H272826 ,H291011 ,H291143 ,H293363 ,H293649 ,H293818  ,H140240 ,H140826 ,H140882 ,H271954 ,H272834 ,H291014 ,H291149 ,H293370 ,H293650 ,H293820  ,H140718 ,H140829 ,H140883 ,H271994 ,H272842 ,H291017 ,H291154 ,H293379 ,H293652 ,H293825  ,H140719 ,H140830 ,H140886 ,H272000 ,H272873 ,H291019 ,H291159 ,H293401 ,H293653 ,H293829  ,H140721 ,H140832 ,H140887 ,H272014 ,H272885 ,H291021 ,H291169 ,H293411 ,H293657 ,H293830  ,H140741 ,H140836 ,H140889 ,H272016 ,H272908 ,H291022 ,H291170 ,H293414 ,H293662 ,H293835  ,H140742 ,H140840 ,H140891 ,H272029 ,H272910 ,H291025 ,H291171 ,H293431 ,H293663 ,H293839  ,H140747 ,H140841 ,H140892 ,H272064 ,H272933 ,H291028 ,H291172 ,H293433 ,H293664 ,H293841  ,H140749 ,H140843 ,H140893 ,H272081 ,H272946 ,H291035 ,H291178 ,H293438 ,H293686 ,H293846  ,H140751 ,H140844 ,H140895 ,H272111 ,H272960 ,H291037 ,H291184 ,H293439 ,H293690 ,H293847,H293848 ,H294007 ,H294135 ,H294244 ,H294332 ,H294415 ,H294500 ,H294567 ,H294656 ,H294732  ,H293860 ,H294012 ,H294140 ,H294246 ,H294338 ,H294418 ,H294501 ,H294568 ,H294657 ,H294735  ,H293866 ,H294013 ,H294141 ,H294248 ,H294340 ,H294420 ,H294505 ,H294569 ,H294658 ,H294739  ,H293872 ,H294020 ,H294146 ,H294252 ,H294342 ,H294423 ,H294508 ,H294571 ,H294660 ,H294742  ,H293875 ,H294022 ,H294149 ,H294256 ,H294343 ,H294425 ,H294509 ,H294572 ,H294661 ,H294744  ,H293878 ,H294023 ,H294150 ,H294263 ,H294345 ,H294426 ,H294513 ,H294573 ,H294665 ,H294745  ,H293880 ,H294024 ,H294155 ,H294264 ,H294347 ,H294427 ,H294514 ,H294581 ,H294666 ,H294747  ,H293886 ,H294032 ,H294157 ,H294265 ,H294348 ,H294429 ,H294517 ,H294587 ,H294667 ,H294750  ,H293888 ,H294033 ,H294158 ,H294266 ,H294350 ,H294430 ,H294518 ,H294589 ,H294668 ,H294752  ,H293889 ,H294035 ,H294162 ,H294267 ,H294351 ,H294431 ,H294520 ,H294590 ,H294671 ,H294753  ,H293890 ,H294037 ,H294163 ,H294268 ,H294352 ,H294433 ,H294521 ,H294591 ,H294674 ,H294754,H293899 ,H294043 ,H294164 ,H294272 ,H294355 ,H294434 ,H294523 ,H294593 ,H294675 ,H294758  ,H293902 ,H294048 ,H294166 ,H294278 ,H294362 ,H294436 ,H294524 ,H294594 ,H294676 ,H294761  ,H293903 ,H294053 ,H294167 ,H294279 ,H294363 ,H294437 ,H294528 ,H294595 ,H294678 ,H294762  ,H293906 ,H294055 ,H294169 ,H294282 ,H294364 ,H294438 ,H294530 ,H294598 ,H294679 ,H294763  ,H293908 ,H294057 ,H294171 ,H294284 ,H294366 ,H294443 ,H294531 ,H294603 ,H294681 ,H294766  ,H293909 ,H294061 ,H294176 ,H294290 ,H294369 ,H294447 ,H294534 ,H294604 ,H294682 ,H294768  ,H293917 ,H294062 ,H294178 ,H294292 ,H294370 ,H294449 ,H294535 ,H294608 ,H294683 ,H294770  ,H293918 ,H294070 ,H294179 ,H294295 ,H294371 ,H294450 ,H294536 ,H294613 ,H294684 ,H294771  ,H293919 ,H294081 ,H294180 ,H294296 ,H294373 ,H294460 ,H294537 ,H294614 ,H294694 ,H294782  ,H293925 ,H294082 ,H294188 ,H294297 ,H294376 ,H294461 ,H294538 ,H294615 ,H294696 ,H294786  ,H293928 ,H294083 ,H294190 ,H294300 ,H294381 ,H294465 ,H294539 ,H294616 ,H294697 ,H294792  ,H293946 ,H294087 ,H294200 ,H294302 ,H294382 ,H294468 ,H294540 ,H294618 ,H294698 ,H294793  ,H293947 ,H294099 ,H294202 ,H294303 ,H294385 ,H294469 ,H294541 ,H294620 ,H294701 ,H294796  ,H293952 ,H294100 ,H294203 ,H294306 ,H294386 ,H294470 ,H294542 ,H294621 ,H294705 ,H294797  ,H293953 ,H294102 ,H294204 ,H294307 ,H294387 ,H294472 ,H294545 ,H294623 ,H294707 ,H294798  ,H293954 ,H294104 ,H294206 ,H294311 ,H294393 ,H294474 ,H294546 ,H294625 ,H294711 ,H294801  ,H293955 ,H294105 ,H294207 ,H294316 ,H294394 ,H294476 ,H294547 ,H294626 ,H294712 ,H294803  ,H293957 ,H294106 ,H294210 ,H294317 ,H294395 ,H294477 ,H294548 ,H294630 ,H294715 ,H294806  ,H293960 ,H294111 ,H294212 ,H294319 ,H294397 ,H294478 ,H294549 ,H294632 ,H294716 ,H294807  ,H293964 ,H294114 ,H294213 ,H294320 ,H294398 ,H294479 ,H294550 ,H294637 ,H294719 ,H294808  ,H293971 ,H294118 ,H294215 ,H294321 ,H294401 ,H294482 ,H294551 ,H294640 ,H294720 ,H294813  ,H293981 ,H294122 ,H294216 ,H294322 ,H294402 ,H294488 ,H294552 ,H294643 ,H294723 ,H294815  ,H293984 ,H294126 ,H294219 ,H294325 ,H294403 ,H294493 ,H294553 ,H294644 ,H294724 ,H294826  ,H293989 ,H294128 ,H294224 ,H294326 ,H294404 ,H294494 ,H294554 ,H294645 ,H294726 ,H294827  ,H293993 ,H294130 ,H294227 ,H294329 ,H294406 ,H294497 ,H294556 ,H294646 ,H294727 ,H294829  ,H294002 ,H294133 ,H294232 ,H294330 ,H294409 ,H294498 ,H294557 ,H294652 ,H294728,H294004 ,H294134 ,H294238 ,H294331 ,H294414 ,H294499 ,H294565 ,H294654 ,H294729
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia.
  • Description du dispositif
    Varian brand Trilogy System with RapidArc, Model Numbers: || H14, H26, H27, H29; Distributed and Manufactured by: || Varian Medical Systems Inc., Palo Alto, CA
  • Manufacturer
    Varian Medical Systems Inc.

Manufacturer

Varian Medical Systems Inc.
  • Adresse du fabricant
    Varian Medical Systems Inc., 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA