Alerta De Seguridad para Multidata Radiotherapy Decision Planning Support Systems. All Product Codes

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Multidata Systems Internacional Corp.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    265
  • Fecha
    2001-11-28
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    In the older versions of the software for the radiotherapy systems, there was acceptance of inappropriately inserted blocks in a different way than was specified in the user manual. when a block is inserted improperly, the software can calculate an unexpected overdose of radiation that may go unnoticed by the user and cause harm to the patient. the manufacturer initiated a voluntary correction work through a letter dated 12.09.01 and sent all customers a software maintenance and maintenance package with a support system entitled project safeguard, which consists of a modified version of the block scanning program.
  • Acción
    Make sure you have received the letter and the package with Project Safeguar. Install the updated Maintenance Pack as instructed on the diskette label. This should take about 35 seconds. A filter that rejects an unacceptable block is included in the modified version of the block scan program. This maintenance update is only a specific upgrade to the block scanning program and will not affect the performance or any other function or configuration of the treatment planning system. For more information, and to notify Multidata's helpdesk after receiving the update package, contact Multidata via telephone in the USA at 1 (314) 968-1001 or 1 (314) 968-6443, or by email: helpdesk@multidata-systems.com.

Manufacturer