Events

Safety Alert for Trade name: LINEAR DIGITAL PRIMUS / MEVATRON ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073/10234230021 Hazard class: III Serial numbers affected: 2809; 2879; 2946; 3054; 1444; 1448; 1397; 1926; 2752; 2346; 2747

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
    2222
  • Date
    2017-02-24
  • 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
    It is recommended to include the Safety Note in the System Owner's Manual.
  • Reason
    Siemens healthcare diagnostics informs that there is a defective welded seal on the upper suspensions. due to this defect, the welded seal may rupture and the upper suspension may fall. this can lead to injury to the patient and / or other people.
  • Action
    Field Action Code TH009 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Trade name: LINEAR DIGITAL PRIMUS / MEVATRON ACCELERATOR Technical name: Linear Accelerator ANVIS...

Manufacturer

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