Retiro De Equipo (Recall) de Device Recall Portal Vision (Electronic Portal Image Device) RArm with 4D Integrated Treatment Console

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Varian Medical Systems, Inc. Oncology Systems.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60684
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0516-2012
  • Fecha de inicio del evento
    2011-11-23
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Accelerator, linear, medical - Product Code IYE
  • Causa
    An anomaly was discovered when using the 4ditc in combination with an r-arm to acquire double exposure mv images.
  • Acción
    The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated December 1, 2011 to all affected sites via Certified mail, return receipt. Canadian accounts were sent by Fed Ex and internationally to Varian International Customer Support Managers for translation and notification of customers. The notice described the product, problem and actions to be taken. The customers were instructed to always acquire both the treatment port and the open port images BEFORE displaying the digital graticule, when using a standard double exposure template; and to advise the appropriate personnel working in their radiotherapy department of the content of this letter. Special instructions for customers outside the USA and Canada: these customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems, once they have read this document. Varian is developing a correction for this issue and a Customer Service rep will contact the customers when the correction is available to schedule its installation on their systems. If you have any questions, contact USA and Canada at 1-888-827-4265; Europe: +41 41 749 8844; Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: China.apps.helpdesk@varian.com; Japan: Japan-Apps.Helpdesk@varian.com and Latin America: soporte.al@varian.com or Internet: Oncology systems customer site: www.myvarian.com and Varian Medical Systems public site: www.varian.com.

Device

  • Modelo / Serial
    Model H80, H81; Serial numbers: H800017 H800447 H800692 H801949 H803815 H803912 H803999 H804090 H804178 H804271 H804348 H804439 H804523 H800031 H800453 H800693 H801951 H803816 H803913 H804000 H804091 H804179 H804272 H804349 H804442 H804524 H800037 H800457 H800696 H801952 H803818 H803914 H804002 H804092 H804188 H804273 H804350 H804443 H804525 H800054 H800467 H800703 H801955 H803822 H803919 H804003 H804094 H804191 H804274 H804351 H804444 H804526 H800060 H800469 H800708 H801969 H803825 H803922 H804004 H804095 H804192 H804275 H804352 H804446 H804527 H800064 H800470 H800710 H801971 H803826 H803923 H804006 H804097 H804193 H804276 H804354 H804447 H804528 H800065 H800474 H800713 H801976 H803827 H803925 H804007 H804099 H804194 H804278 H804355 H804448 H804529 H800073 H800489 H800714 H801986 H803828 H803928 H804008 H804100 H804198 H804279 H804356 H804449 H804530 H800077 H800490 H800800 H801991 H803829 H803930 H804009 H804101 H804199 H804280 H804358 H804450 H804531 H800079 H800498 H800801 H801993 H803830 H803932 H804010 H804105 H804200 H804281 H804362 H804451 H804534 H800085 H800500 H800802 H801994 H803834 H803933 H804012 H804106 H804202 H804282 H804364 H804452 H804535 H800091 H800501 H800812 H801996 H803835 H803934 H804013 H804108 H804203 H804284 H804365 H804454 H804536 H800095 H800503 H800819 H801997 H803836 H803935 H804014 H804111 H804205 H804287 H804367 H804455 H804537 H800096 H800505 H800827 H802000 H803838 H803937 H804015 H804112 H804207 H804288 H804368 H804456 H804540 H800100 H800521 H800844 H802011 H803840 H803938 H804017 H804113 H804208 H804289 H804370 H804458 H804541 H800103 H800522 H800859 H802017 H803841 H803940 H804018 H804114 H804209 H804291 H804371 H804459 H804542 H800109 H800527 H800860 H802019 H803845 H803941 H804021 H804115 H804212 H804294 H804372 H804461 H804543 H800133 H800528 H800868 H802022 H803847 H803942 H804023 H804116 H804213 H804295 H804373 H804464 H804544 H800138 H800532 H800885 H802026 H803848 H803945 H804025 H804118 H804215 H804296 H804374 H804465 H804545 H800141 H800537 H800887 H802030 H803849 H803948 H804027 H804119 H804216 H804298 H804375 H804466 H804547 H800143 H800538 H800888 H802032 H803852 H803949 H804028 H804120 H804217 H804299 H804376 H804468 H804548 H800147 H800541 H800913 H802033 H803853 H803951 H804029 H804121 H804218 H804300 H804377 H804471 H804549 H800181 H800542 H800919 H802034 H803855 H803954 H804030 H804122 H804220 H804302 H804380 H804473 H804551 H800194 H800545 H800920 H802035 H803857 H803955 H804033 H804123 H804221 H804305 H804382 H804474 H804552 H800195 H800555 H800923 H802036 H803859 H803958 H804034 H804124 H804222 H804308 H804383 H804476 H804554 H800198 H800566 H800925 H802038 H803860 H803959 H804036 H804125 H804227 H804309 H804384 H804477 H804555 H800202 H800567 H800929 H802057 H803863 H803960 H804037 H804128 H804228 H804310 H804386 H804479 H804556 H800219 H800574 H800947 H802058 H803865 H803963 H804038 H804129 H804229 H804311 H804387 H804482 H804557 H800220 H800575 H801325 H802061 H803866 H803964 H804039 H804132 H804230 H804312 H804388 H804483 H804558 H800227 H800580 H801336 H802062 H803869 H803965 H804044 H804135 H804232 H804314 H804390 H804484 H804560 H800231 H800585 H801460 H802069 H803870 H803966 H804045 H804136 H804233 H804315 H804392 H804485 H804561 H800238 H800586 H801805 H802070 H803871 H803967 H804047 H804137 H804234 H804316 H804393 H804487 H804563 H800241 H800598 H801806 H802072 H803872 H803968 H804049 H804138 H804235 H804317 H804394 H804488 H804565 H800242 H800600 H801807 H802073 H803873 H803969 H804050 H804140 H804238 H804319 H804395 H804489 H804566 H800252 H800602 H801813 H802079 H803875 H803970 H804051 H804141 H804239 H804320 H804396 H804491 H804567 H800257 H800614 H801819 H802086 H803876 H803971 H804052 H804142 H804240 H804321 H804402 H804492 H804568 H800260 H800616 H801824 H802087 H803879 H803973 H804053 H804143 H804241 H804322 H804403 H804493 H804569 H800265 H800617 H801845 H802092 H803880 H803974 H804054 H804144 H804242 H804323 H804407 H804494 H804570 H800271 H800618 H801849 H802094 H803883 H803975 H804055 H804146 H804243 H804324 H804408 H804495 H804572 H800274 H800625 H801851 H802096 H803884 H803977 H804056 H804147 H804244 H804325 H804414 H804497 H804573 H800278 H800626 H801856 H802097 H803885 H803978 H804059 H804148 H804245 H804326 H804415 H804500 H804574 H800296 H800632 H801863 H802100 H803886 H803979 H804060 H804149 H804246 H804327 H804416 H804501 H804575 H800298 H800634 H801869 H802101 H803887 H803981 H804063 H804150 H804247 H804329 H804417 H804502 H804576 H800315 H800637 H801874 H802105 H803889 H803982 H804064 H804151 H804251 H804330 H804418 H804503 H804577 H800327 H800638 H801889 H802107 H803890 H803983 H804066 H804156 H804253 H804331 H804419 H804505 H804580 H800333 H800641 H801912 H802110 H803893 H803984 H804068 H804159 H804254 H804332 H804420 H804508 H804581 H800335 H800643 H801915 H802111 H803894 H803985 H804070 H804160 H804255 H804333 H804422 H804510 H804584 H800339 H800646 H801916 H802112 H803896 H803986 H804071 H804161 H804256 H804334 H804424 H804511 H804586 H800343 H800648 H801917 H802116 H803897 H803987 H804072 H804162 H804257 H804335 H804425 H804512 H804588 H800419 H800654 H801926 H802118 H803898 H803988 H804073 H804163 H804259 H804338 H804426 H804513 H804589 H800421 H800655 H801934 H802133 H803900 H803989 H804074 H804165 H804261 H804339 H804427 H804515 H804591 H800423 H800660 H801935 H802283 H803901 H803990 H804080 H804166 H804262 H804340 H804428 H804516 H804592 H800425 H800662 H801938 H802402 H803904 H803991 H804081 H804167 H804264 H804341 H804429 H804517 H804599 H800429 H800665 H801940 H802925 H803905 H803993 H804083 H804168 H804265 H804342 H804430 H804518 H804600 H800434 H800670 H801942 H803043 H803907 H803994 H804084 H804172 H804266 H804343 H804431 H804519 H804601 H800435 H800679 H801943 H803382 H803908 H803995 H804085 H804175 H804267 H804344 H804432 H804520 H804602 H800438 H800689 H801944 H803608 H803910 H803997 H804087 H804176 H804268 H804346 H804434 H804521 H804606 H800444 H800690 H801945 H803806 H803911 H803998 H804089 H804177 H804270 H804347 H804438 H804522 H804607
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France,, Georgia, Germany,Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Lativia, Macedonia, Malaysia, Martinique, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    Portal Vision, R-Arm with 4D Integrated Treatment Console; || Varian Medical Systems. Palo Alto, CA. || The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA