Events

Alerte De Sécurité sur Multidata Radiotherapy Decision Planning Support Systems. All Product Codes

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Multidata Systems Internacional Corp.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    265
  • Date
    2001-11-28
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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.

Device

Multidata Radiotherapy Decision Planning Support Systems. All Product Codes

Manufacturer

Multidata Systems Internacional Corp
  • Source
    ANVSANVISA