Events

Safety Alert for RM Magnetom apparatus, Open model, Impact and Vision, registration 10234230012, series: 7449; 5709; 9190; 15024; 15517 /// RM Magnetom Symphony Equipment, registration 10234230057, series: 13131; 13286; 13424; 13564; 22202; 22379; 22388; 22389; 22448; 22460; 22583; 22744; 23207; 23286; 37503. /// Equipment of RM Magnetom Sonata, registration 10234230089, series: 21120; 21179; 21271 /// Equipment of RM Magnetom Spectra, registration 10345161996 (original registration 10234230182), series: 73002; 73003 /// Magnetom Avanto, registration 10345162003 (original registration: 10234230095), series: 57140; 57206; 57241; 59081. /// Magnetom Essenza, registration 10345162004 (original registration 10234230155), series: 64132; 71310; 71326; 71330; 71338; 71341; 71343; 71347; 71349; 71350; 71355; 71357; 71358; 71359; 71361; 71362; 71365; 71366; 71381; 71384. /// Equipment of RM Magnetom Prisma, registration 10345162015 (original registration 10234230203), series: 67047; 67051. /// Equipment of RM Magnetom Aera, registration 10345162032 (original registration 10234230175), series: 41904; 41909; 41986; 42031; 53501; 53502. /// Magnetom Harmony Equipment, registration 10234230056.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Shenzhen Magnetic Resonance Ltd.; Siemens Healthcare Diagnósticos S.A.

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
    1782
  • Date
    2015-12-23
  • 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
    Suppressor lines in magnetic resonance systems serve to vent helium gas in case of dissipation. In the event of installation failure, the helium gas would be blown into the magnet room or other areas. This could lead to a displacement of the local oxygen gas, cause cold burns and / or pose a risk to users, patients and others.
  • Reason
    Siemens healthcare comes across the letter mr047 / 15 / s to alert its customers in brazil about the possibility that the suppressor lines of some superconducting magnets have not been installed properly.
  • Action
    The field action code MR047 / 15 / S initiated by Siemens addresses the sending of a Risk Letter III to the Customer (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences ). Recommendation to Users and Patients: Proprietary MRI customers must follow one of the steps below, depending on who performed the MRI suppression facility. The guideline is for customers to have the equipment inspected for installation to assess the existence of the problem. 1) If Siemens has been contracted to install the suppressor line, contact the local Siemens organization for appropriate action. 2) If a third party has been contracted to install the suppressor line, it is recommended that they be contacted and requested to inspect the suppressor line in order to ensure that it has been installed in accordance with the system owner's manual and in accordance with requirements in the design document of the Siemens suppressor line. Notwithstanding, and alternately, Siemens makes itself available to offer users the possibility of requesting an inspection of the installation, after which it will be informed of the result and any identified deficiencies that need to be resolved. Finally, it is important to note that it is important to follow all the guidelines mentioned in the system owner's manual, including ensuring that there is an on-site emergency plan in the event of helium gas dissipation to the magnet room or adjoining rooms.

Device

RM Magnetom apparatus, Open model, Impact and Vision, registration 10234230012, series: 7449; 570...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Shenzhen Magnetic Resonance Ltd.; Siemen...
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA