Events

Safety Alert for Equipment Affected: X-ray system for Meratron M Therapy, registration 10234230021, risk class III, series affected: 3229; 3554; 3559; 3581; 3585; 3588; 3589; 3655; 3787; 3857; 3889; 3903; 3906; 3911; 3913; 3927; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 70-4118; 70-4203. /// Linear Accelerator PRIMUS HI, registration 10234230073, Class of risk III, series affected: 3598; 3752; 5509; 5526. /// Oncor linear accelerator, registry 10234230125, risk class III, series affected: 5287; 5386.

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

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
    1626
  • Date
    2015-05-25
  • 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 manufacturer there is a possibility of collision of the linear accelerator gantry with the patient or the treatment table.
  • Reason
    When the equipment is switched on, it checks if the position of the gantry has changed when the equipment has been switched off. in some cases, it has been identified as changed, even though it has not been changed since the shutdown. in these cases, the console display starts to flash.
  • Action
    The company that holds the registry will upgrade the control console software to version 9.2.400.

Device

Equipment Affected: X-ray system for Meratron M Therapy, registration 10234230021, risk class III...

Manufacturer

Siemens Ltda.; SIEMENS Medical System, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA