Events

Alerte De Sécurité sur Magnetic Resonance Imaging Equipment, SIEMENS Brand, Risk Class II, of the following models :. - Magnetom Aera / Magnetom Skya, Registry: 10234230175 ///. - Magnetom Avanto, Registry: 10234230095 ///. - Magnetom Espree, Registry: 10234230115 ///. - Magnetom Essenza and Verio, Registry: 10234230155 ///. - Magnetom Harmony, Registry: 10234230056 (hazard class III) ///. - Magnetom Sonata, Record: 10234230089 ///. - Magnetom Spectra, Registry: 10234230182 ///. - Magnetom Symphony, Registry: 10234230057 ///. - Magnetom Trio, Registry: 10234230098 ///. Serial numbers: attached.

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 AG Medical Solutions Group..

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
    1515
  • Date
    2014-11-24
  • 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 holder of the registration informs: "The possibility of a rupture in the quench tube, which may cause the helium gas to leak into the magnetic room or any other area near the quench tube. In rare cases, this helium gas may lead to a displacement of oxygen in the air causing danger by asphyxiation in people in the area. Other hazards, such as freezing, can be caused by the extremely low temperatures of helium gas. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    Siemens has detected that in some cases siemens magnetom systems with superconducting magnets may have been installed by omitting essential safety requirements for the installation of the quench tube.
  • Action
    The registration company advises users to wait for the quench tube check by the Siemens team. If, during the inspection, you detect any discrepancies with the requirements of Siemens, the user will be informed separately about the type of divergence together with a plan of how it will be corrected. (SEE ANNEX CUSTOMER LETTER)

Device

Magnetic Resonance Imaging Equipment, SIEMENS Brand, Risk Class II, of the following models :. - ...

Manufacturer

Siemens Ltda.; SIEMENS AG Medical Solutions Group.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA