Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; SIEMENS AG Medical Solutions Group..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1515
  • Date
    2014-11-24
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA