Events

Rappel de Device Recall Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator,

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 Oncology Systems.

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
    56350
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0892-2011
  • Date de mise en oeuvre de l'événement
    2010-01-19
  • Date de publication de l'événement
    2011-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93282
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
  • Cause
    There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.
  • Action
    Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin. Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure. Previous wear measurements should be compared to new measurements and any large increase in wear should be investigated immediately. Pay special attention to the "Recommendations based on wear measurements" table. Ensure that new wear measurements comply with the operating parameters described in the table. For any questions consignees are to contact Varian Medical Systems Customer Support Services at one of the locations described in the CTB. For questions regarding this recall call (650) 424-5731.

Device

Device Recall Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator,
  • Modèle / numéro de série
    Listed are the affected system Serial Numbers. The last four digits represent the serial number of the device.  H720003 ,H720119 ,H720209 ,H720270 ,H720347 ,H720416 ,H720491 ,H720557 ,H720618, H720006 ,H720122 ,H720210 ,H720271 ,H720348 ,H720417 ,H720495 ,H720558 ,H720620, H720009 ,H720123 ,H720211 ,H720273 ,H720350 ,H720419 ,H720496 ,H720559 ,H720622, H720013 ,H720124 ,H720213 ,H720274 ,H720351 ,H720422 ,H720498 ,H720560 ,H720624, H720015 ,H720125 ,H720215 ,H720276 ,H720352 ,H720424 ,H720499 ,H720561 ,H720626, H720017 ,H720129 ,H720217 ,H720279 ,H720353 ,H720425 ,H720500 ,H720562 ,H720627, H720021 ,H720132 ,H720218 ,H720280 ,H720354 ,H720427 ,H720501 ,H720563 ,H720628, H720022 ,H720133 ,H720219 ,H720281 ,H720355 ,H720429 ,H720502 ,H720565 ,H720629, H720025 ,H720134 ,H720221 ,H720282 ,H720357 ,H720432 ,H720503 ,H720566 ,H720632, H720035 ,H720137 ,H720222 ,H720283 ,H720358 ,H720435 ,H720505 ,H720567 ,H720637, H720037 ,H720138 ,H720225 ,H720284 ,H720362 ,H720437 ,H720506 ,H720568 ,H720638, H720040 ,H720140 ,H720229 ,H720288 ,H720363 ,H720438 ,H720508 ,H720571 ,H720639, H720041 ,H720143 ,H720230 ,H720289 ,H720367 ,H720439 ,H720509 ,H720572 ,H720641, H720048 ,H720144 ,H720231 ,H720290 ,H720373 ,H720440 ,H720511 ,H720573 ,H720642, H720051 ,H720145 ,H720232 ,H720292 ,H720374 ,H720442 ,H720513 ,H720575 ,H720643, H720052 ,H720148 ,H720233 ,H720293 ,H720375 ,H720443 ,H720514 ,H720577 ,H720644, H720056 ,H720152 ,H720234 ,H720294 ,H720376 ,H720445 ,H720515 ,H720578 ,H720647, H720057 ,H720154 ,H720235 ,H720295 ,H720379 ,H720447 ,H720516 ,H720579 ,H720648, H720059 ,H720157 ,H720236 ,H720296 ,H720383 ,H720449 ,H720518 ,H720584 ,H720650, H720060 ,H720159 ,H720237 ,H720297 ,H720384 ,H720452 ,H720522 ,H720585 ,H720651, H720064 ,H720164 ,H720239 ,H720298 ,H720386 ,H720457 ,H720523 ,H720586 ,H720653, H720069 ,H720165 ,H720241 ,H720299 ,H720388 ,H720458 ,H720525 ,H720588 ,H720654, H720070 ,H720167 ,H720242 ,H720300 ,H720391 ,H720461 ,H720526 ,H720589 ,H720659, H720071 ,H720168 ,H720245 ,H720303 ,H720392 ,H720465 ,H720528 ,H720590 ,H720660, H720072 ,H720169 ,H720247 ,H720307 ,H720394 ,H720466 ,H720530 ,H720591 ,H720661, H720074 ,H720177 ,H720248 ,H720309 ,H720395 ,H720470 ,H720531 ,H720592 ,H720663, H720075 ,H720180 ,H720251 ,H720316 ,H720396 ,H720471 ,H720533 ,H720594 ,H720664, H720082 ,H720181 ,H720254 ,H720320 ,H720397 ,H720472 ,H720534 ,H720595 ,H720666, H720083 ,H720182 ,H720255 ,H720327 ,H720399 ,H720477 ,H720536 ,H720596 ,H720667, H720088 ,H720183 ,H720256 ,H720328 ,H720402 ,H720478 ,H720537 ,H720597 ,H720668, H720089 ,H720185 ,H720257 ,H720329 ,H720403 ,H720479 ,H720539 ,H720598 ,H720669, H720092 ,H720186 ,H720258 ,H720330 ,H720404 ,H720481 ,H720546 ,H720599 ,H720670, H720098 ,H720187 ,H720261 ,H720336 ,H720405 ,H720482 ,H720547 ,H720600 ,H720671, H720101 ,H720188 ,H720262 ,H720337 ,H720406 ,H720484 ,H720548 ,H720601 ,H720672, H720106 ,H720195 ,H720263 ,H720338 ,H720407 ,H720485 ,H720550 ,H720604 ,H720673, H720107 ,H720196 ,H720264 ,H720339 ,H720409 ,H720486 ,H720553 ,H720605 ,H720674, H720108 ,H720199 ,H720265 ,H720344 ,H720411 ,H720487 ,H720554 ,H720608 ,H720675, H720112 ,H720200 ,H720266 ,H720345 ,H720414 ,H720488 ,H720555 ,H720615 ,H720676, H720113 ,H720204 ,H720269 ,H720346 ,H720415 ,H720489 ,H720556 ,H720616 ,H720678,   H720679 ,H720743 ,H720805 ,H720858 ,H720905 ,H720955 ,H721005, H720680 ,H720744 ,H720806 ,H720859 ,H720906 ,H720956 ,H721006, H720681 ,H720746 ,H720807 ,H720860 ,H720907 ,H720957 ,H721007, H720682 ,H720747 ,H720808 ,H720861 ,H720908 ,H720958 ,H721008, H720683 ,H720748 ,H720809 ,H720862 ,H720909 ,H720959 ,H721009, H720684 ,H720749 ,H720810 ,H720863 ,H720910 ,H720960 ,H721010, H720686 ,H720750 ,H720811 ,H720864 ,H720911 ,H720961 ,H721011, H720688 ,H720752 ,H720812 ,H720865 ,H720913 ,H720962 ,H721012, H720689 ,H720754 ,H720813 ,H720866 ,H720914 ,H720963 ,H721013, H720692 ,H720756 ,H720814 ,H720867 ,H720915 ,H720964 ,H721014, H720693 ,H720759 ,H720815 ,H720868 ,H720916 ,H720965 ,H721015, H720694 ,H720760 ,H720816 ,H720869 ,H720918 ,H720966 ,H721016, H720697 ,H720761 ,H720817 ,H720870 ,H720919 ,H720967 ,H721017, H720699 ,H720763 ,H720818 ,H720871 ,H720920 ,H720968 ,H721018, H720701 ,H720766 ,H720819 ,H720872 ,H720921 ,H720969 ,H721019, H720702 ,H720767 ,H720820 ,H720873 ,H720922 ,H720974 ,H721020, H720704 ,H720769 ,H720822 ,H720874 ,H720923 ,H720975 ,H721022, H720705 ,H720770 ,H720823 ,H720875 ,H720925 ,H720976 ,H721023, H720706 ,H720773 ,H720824 ,H720876 ,H720926 ,H720977 ,H721024, H720707 ,H720774 ,H720825 ,H720877 ,H720927 ,H720978 ,H721025, H720711 ,H720775 ,H720826 ,H720878 ,H720928 ,H720979 ,H721026, H720712 ,H720776 ,H720827 ,H720879 ,H720929 ,H720980 ,H721027, H720714 ,H720777 ,H720829 ,H720880 ,H720930 ,H720981 ,H721028, H720715 ,H720778 ,H720830 ,H720881 ,H720931 ,H720982 ,H721029, H720716 ,H720780 ,H720831 ,H720882 ,H720932 ,H720983 ,H721030, H720718 ,H720781 ,H720832 ,H720883 ,H720933 ,H720984 ,H721031, H720719 ,H720782 ,H720833 ,H720884 ,H720935 ,H720985 ,H721032, H720720 ,H720783 ,H720834 ,H720885 ,H720936 ,H720986 ,H721033, H720721 ,H720784 ,H720835 ,H720886 ,H720937 ,H720987 ,H721034, H720722 ,H720786 ,H720836 ,H720888 ,H720938 ,H720988 ,H721035, H720723 ,H720787 ,H720840 ,H720889 ,H720940 ,H720989 ,H721036, H720724 ,H720788 ,H720841 ,H720890 ,H720941 ,H720990 ,H721037, H720725 ,H720790 ,H720842 ,H720891 ,H720942 ,H720991 ,H721038, H720726 ,H720792 ,H720843 ,H720892 ,H720943 ,H720992 ,H721039, H720727 ,H720795 ,H720844 ,H720894 ,H720945 ,H720993 ,H721040, H720728 ,H720796 ,H720847 ,H720895 ,H720946 ,H720995 ,H721041, H720729 ,H720797 ,H720848 ,H720896 ,H720947 ,H720996 ,H721042, H720732 ,H720798 ,H720849 ,H720897 ,H720948 ,H720997 ,H721043, H720733 ,H720799 ,H720851 ,H720898 ,H720949 ,H720998 ,H721044, H720734 ,H720800 ,H720852 ,H720899 ,H720950 ,H720999 ,H721045, H720737 ,H720801 ,H720854 ,H720901 ,H720951 ,H721000 ,H721046, H720739 ,H720802 ,H720855 ,H720902 ,H720952 ,H721001 ,H721047, H720741 ,H720803 ,H720856 ,H720903 ,H720953 ,H721002 ,H721048, H720742 ,H720804 ,H720857 ,H720904 ,H720954 ,H721004
  • Classification du dispositif
    Radiology Devices
  • Distribution
    Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.
  • Description du dispositif
    Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, || Model H72, Product is manufactured and distributed by Varian Oncology Systems, || Palo Alto, CA || The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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