Events

Alerte De Sécurité sur X-ray System for Mevatron Therapy M, Registry 10234230021 - Serial Numbers: 3054; 3221; 3229; 3589; 3588; 3581; 3585; 3559; 3554; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 2752; 3655; 3787; 3857; 3889; 3913; 3906; 3911; 3927; 3903; 70-4118; 70-4203; 2346; 2946; 2747; 2809; 2651; 2879; 2591.

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 Systems.

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
    1496
  • Date
    2015-01-19
  • 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
    The registry holder informs that if there is plaque overheating, there is potential for a fire or even smoke emission from the system to be inhaled and consequently medical treatment may be required, depending on the patient's distance and the amount of smoke emitted.
  • Cause
    Siemens has identified a possible occurrence of sporadic failure of overheating signals on the g41 motherboard, located within the gantry of the linear accelerator. one of the components belonging to the printed circuit board (pcb of the head driver) was determined as the root cause.
  • Action
    Siemens has redesigned the Hard Driver PCB card to further mitigate the risk of local superheat of the G41 motherboard and is guiding customers to wait for the patch to be replaced in the field to replace the card for which it has been redesigned, to file the letter to the client, and follow the guidelines contained in the letter.

Device

X-ray System for Mevatron Therapy M, Registry 10234230021 - Serial Numbers: 3054; 3221; 3229; 358...

Manufacturer

Siemens Ltda.; Siemens Medical Systems
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA