Events

Retiro De Equipo (Recall) de Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL

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
    61012
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0945-2012
  • Fecha de inicio del evento
    2011-11-10
  • Fecha de publicación del evento
    2012-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107038
  • 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
    Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with the treatment field defined by the brainlab m3 without an interlock being asserted.
  • Acción
    The firm, Varian Medical Systems, Inc., sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated November 10, 2011 to all affected users. The letter describes the product, description of problem, details, recommended actions and Varian's actions. Varian Service will contact customers to arrange installation, once modifications are available. ***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 also included special instructions for customers outside the USA and Canada. The customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems once they have read the document. If you require further clarification, feel fee to contact your local Varian Customer Support District or Regional Manager at: USA and Canada: 1-888-VARIANS (1-888-827-4265); Europe: +41 41 749 8844; or Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com; 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

Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL
  • Modelo / Serial
    H530001 ,H530075 ,H530439 ,H533043 ,H535023 ,H535082 ,H535128 ,H535180 ,H535220 ,H530004 ,H530078 ,H531008 ,H534004 ,H535024 ,H535084 ,H535131 ,H535181 ,H535867 ,H530008 ,H530082 ,H531010 ,H534015 ,H535025 ,H535085 ,H535133 ,H535182 ,H536005 ,H530012 ,H530084 ,H531020 ,H534020 ,H535030 ,H535086 ,H535135 ,H535183 ,H536452 ,H530014 ,H530085 ,H531025 ,H534021 ,H535031 ,H535087 ,H535137 ,H535184 ,H536465 ,H530018 ,H530087 ,H531029 ,H534022 ,H535033 ,H535088 ,H535141 ,H535186 ,H536479 ,H530021 ,H530104 ,H531033 ,H534026 ,H535035 ,H535091 ,H535142 ,H535188 ,H530022 ,H530204 ,H531035 ,H534032 ,H535036 ,H535094 ,H535144 ,H535190 ,H530023 ,H530231 ,H531038 ,H534036 ,H535039 ,H535098 ,H535147 ,H535191 ,H530024 ,H530250 ,H531041 ,H534040 ,H535043 ,H535099 ,H535149 ,H535192 ,H530030 ,H530311 ,H531043 ,H534223 ,H535044 ,H535100 ,H535151 ,H535193 ,H530034 ,H530323 ,H531044 ,H535003 ,H535045 ,H535104 ,H535154 ,H535194 ,H530035 ,H530339 ,H532005 ,H535004 ,H535046 ,H535105 ,H535157 ,H535195 ,H530036 ,H530340 ,H532006 ,H535005 ,H535047 ,H535106 ,H535159 ,H535197 ,H530045 ,H530396 ,H532014 ,H535008 ,H535053 ,H535108 ,H535161 ,H535199 ,H530046 ,H530401 ,H532021 ,H535009 ,H535054 ,H535109 ,H535162 ,H535200 ,H530049 ,H530405 ,H532027 ,H535012 ,H535055 ,H535111 ,H535164 ,H535201 ,H530050 ,H530417 ,H533004 ,H535013 ,H535056 ,H535115 ,H535166 ,H535207 ,H530051 ,H530423 ,H533008 ,H535014 ,H535058 ,H535116 ,H535167 ,H535209 ,H530055 ,H530425 ,H533014 ,H535015 ,H535068 ,H535117 ,H535168 ,H535211 ,H530057 ,H530427 ,H533027 ,H535016 ,H535070 ,H535120 ,H535169 ,H535213 ,H530063 ,H530428 ,H533028 ,H535017 ,H535072 ,H535121 ,H535173 ,H535214 ,H530064 ,H530429 ,H533029 ,H535018 ,H535073 ,H535122 ,H535176 ,H535215 ,H530066 ,H530430 ,H533036 ,H535020 ,H535076 ,H535123 ,H535177 ,H535218 ,H530068 ,H530433 ,H533037 ,H535021 ,H535081 ,H535124 ,H535178 ,H535219,  ***12-12-12, AMENDED INFO ***: ,H513353 ,H51B100 ,H514449 ,H51B240 ,H517726 ,H51B242 ,H51B083 ,H51B320
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Algeria, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Korea, Spain, Sri Lanka, Sweden, Taiwan, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

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