Events

Safety Alert for Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073 Hazard class: III Serial numbers affected: 5529; 5746; 5828

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 Medical Solutions USA, 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
    2225
  • Date
    2017-03-14
  • 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
    Despite security measures, there may be scenarios that are not covered by the software. Therefore, during automatic sequencing, the operator must pay attention to any movements of the gantry and the treatment table, and deviations or overlaps of the table applied in accordance with the treatment plan and carry out the preventive measures described in the letter of notification TH012 / 14 / S.
  • Reason
    Siemens healthcare diagnostics reports that previous afs motion protection software considered only the critical definitions of isocentric and eccentric table positions, but not a lateral deviation from the treatment table. in addition, the previous software required that the table setting be set to "automatic" in all parameters. if the operator had set the table's isocentric rotation to "manually" and the order of movements to "table first", the previous software ignored this setting. if a move from the gantry and the table to the next treatment field was required, the software did not stop the afs so as to allow manual table movement before the gantry moves, which would be automatically moved to the next target position.
  • Action
    Field Action Code TH005 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration numb...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA