Events

Retiro De Equipo (Recall) de Head Ring Posts; of the Optical Guidance Platform and Floorstand devices

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
    60238
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0332-2012
  • Fecha de inicio del evento
    2011-10-04
  • Fecha de publicación del evento
    2011-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104850
  • 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 has been identified with the head ring posts used by both the optical guidance platform framearray module and the floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.
  • Acción
    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated October 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are advised to verify that they are using the current design of the head ring posts (part # 970.284) and to contact Varian if replacements are needed. Customers may contact the Varian Help Desk for questions regarding this notice at 1-888-827-4265.

Device

Head Ring Posts; of the Optical Guidance Platform and Floorstand devices
  • Modelo / Serial
    Model H48: Head ring Post part number 970.280 Code numbers:  HZ50004 HZ70169 HZ70426 HZ70617 HZ70743 HZ72001 HZ72037 HZ72064 HZ72089 HZ73039 HZ77007 HZ50468 HZ70181 HZ70460 HZ70620 HZ70762 HZ72002 HZ72038 HZ72067 HZ72090 HZ73041 HZ77010 HZ50567 HZ70182 HZ70465 HZ70629 HZ71001 HZ72003 HZ72039 HZ72068 HZ72091 HZ73042 HZ77011 HZ50671 HZ70190 HZ70466 HZ70640 HZ71002 HZ72004 HZ72040 HZ72069 HZ72094 HZ73044 HZ77027 HZ59006 HZ70223 HZ70486 HZ70646 HZ71003 HZ72005 HZ72041 HZ72070 HZ72095 HZ73046 HZ77040 HZ59011 HZ70231 HZ70495 HZ70649 HZ71004 HZ72006 HZ72042 HZ72071 HZ72096 HZ73047 HZ77062 HZ59014 HZ70258 HZ70500 HZ70656 HZ71005 HZ72007 HZ72043 HZ72072 HZ72098 HZ73049 HZ77069 HZ59016 HZ70273 HZ70507 HZ70670 HZ71006 HZ72008 HZ72046 HZ72073 HZ72101 HZ73050 HZ77077 HZ59017 HZ70274 HZ70508 HZ70674 HZ71007 HZ72009 HZ72047 HZ72074 HZ72103 HZ73053 HZ77081 HZ59018 HZ70283 HZ70509 HZ70675 HZ71008 HZ72012 HZ72048 HZ72075 HZ72107 HZ73055 HZ78330 HZ59020 HZ70293 HZ70513 HZ70681 HZ71009 HZ72013 HZ72049 HZ72077 HZ72108 HZ73059 HZ79012 HZ59139 HZ70294 HZ70537 HZ70684 HZ71011 HZ72015 HZ72052 HZ72080 HZ72125 HZ73060 HZ79020 HZ59997 HZ70299 HZ70540 HZ70696 HZ71013 HZ72016 HZ72054 HZ72081 HZ72126 HZ73062 HZ79113 HZ59998 HZ70351 HZ70548 HZ70698 HZ71014 HZ72023 HZ72055 HZ72082 HZ72190 HZ73064 HZ79144 HZ70044 HZ70355 HZ70550 HZ70703 HZ71017 HZ72026 HZ72056 HZ72083 HZ73020 HZ75070 HZ79185 HZ70050 HZ70368 HZ70557 HZ70712 HZ71019 HZ72027 HZ72057 HZ72084 HZ73021 HZ75480 HZ79998 HZ70061 HZ70398 HZ70585 HZ70725 HZ71021 HZ72029 HZ72058 HZ72085 HZ73022 HZ76066  HZ70083 HZ70403 HZ70594 HZ70731 HZ71022 HZ72030 HZ72060 HZ72086 HZ73026 HZ76118  HZ70108 HZ70404 HZ70603 HZ70737 HZ71023 HZ72033 HZ72061 HZ72087 HZ73030 HZ77002  HZ70154 HZ70405 HZ70612 HZ70740 HZ71024 HZ72036 HZ72062 HZ72088 HZ73031 HZ77003.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices. || Varian Medical Systems, Palo Alto, CA 94304. || The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions.
  • 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