Events

Safety Alert for Technical Name: Linear Accelerator ANVISA Registration Number: 10234230125/10234230172/10234230073 Hazard Class: III Model Affected: Acceptable MD4 Serial numbers affected: 3221; 3229; 3554; 3585; 3589; 3655; 3787; 3857; 3889; 3903; 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; 3598; 3752; 5508; 5509; 5526; 5287; 5529; 5386; 5746; 5828; 5867

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
    2220
  • 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 reports that incorrect values ​​for the position of the rotational collimator are displayed. this may occur if the slider, on which the sensors used to detect the position of the rotational collimator are mounted, is not fully engaged. to keep the sensor slider in place, a locking plate must be mounted on the sensor slider. this will significantly reduce the risk of the sensor slider mechanically misalign and display incorrect values ​​for the position of the rotational collimator.
  • Action
    Field Action Code TH008 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Technical Name: Linear Accelerator ANVISA Registration Number: 10234230125/10234230172/1023423007...

Manufacturer

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