Events

Safety Alert for Magnetic Resonance Equipment, record 80005260011. Serial Number Y012

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by HITACHI SISTEMAS MÉDICOS DO BRASIL LTDA.; Hitachi Medical Corporation.

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
    1432
  • Date
    2014-10-02
  • 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
    According to the manifestation of the company, the root cause of this failure has already been determined. The company believes that the risk of injury is low but, as a precaution, decided to change the materials used in the Gradiente Coil to reduce the risk of recurrence and to mitigate any risk of damage. Corrective action will be applied to systems installed before 1 August. The company also reports that only one equipment was installed in Brazil.
  • Reason
    One of the gradient coils on the installed base of the echelon oval suffered a flaw that resulted in a small amount of smoke in the magnet room and a sound accompanying the event. there were no injuries as the system is designed to provide adequate protection and contain these types of system failures. in this particular case, the fault occurred under the back of the patient's "tunnel". this problem has been identified in the united states.
  • Action
    The company that holds the registration in Brazil informs that there are no restrictions on the use of the system until field correction occurs.

Device

Magnetic Resonance Equipment, record 80005260011. Serial Number Y012

Manufacturer

HITACHI SISTEMAS MÉDICOS DO BRASIL LTDA.; Hitachi Medical Corporation
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    ANVSANVISA