Events

Alerte De Sécurité sur Equipment Affected: X-ray system for Meratron M Therapy, registration 10234230021, risk class III, series affected: 3229; 3554; 3559; 3581; 3585; 3588; 3589; 3655; 3787; 3857; 3889; 3903; 3906; 3911; 3913; 3927; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 70-4118; 70-4203. /// Linear Accelerator PRIMUS HI, registration 10234230073, Class of risk III, series affected: 3598; 3752; 5509; 5526. /// Oncor linear accelerator, registry 10234230125, risk class III, series affected: 5287; 5386.

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 Siemens Ltda.; SIEMENS Medical System, Inc..

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
    1626
  • Date
    2015-05-25
  • 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
    According to the manufacturer there is a possibility of collision of the linear accelerator gantry with the patient or the treatment table.
  • Cause
    When the equipment is switched on, it checks if the position of the gantry has changed when the equipment has been switched off. in some cases, it has been identified as changed, even though it has not been changed since the shutdown. in these cases, the console display starts to flash.
  • Action
    The company that holds the registry will upgrade the control console software to version 9.2.400.

Device

Equipment Affected: X-ray system for Meratron M Therapy, registration 10234230021, risk class III...

Manufacturer

Siemens Ltda.; SIEMENS Medical System, Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA