Events

Safety Alert for LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Number: 100041.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; 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
    1677
  • Date
    2015-08-27
  • 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
    If the dose or the time of treatment is affected, the patient may receive an excessive dose and the consequences may be lethal. If a geometric parameter is affected (field size, depth, angle) there may be a geometric error and the target may receive a lower than recommended dose, while normal structures may receive an excessive dose. This can result in serious health consequences. However, Siemens notes that the error described by the manufacturer ELEKTA has not been observed with systems installed and configured in accordance with the Siemens procedure. Therefore, unless the system configuration has been changed or acquired additional modules after delivery of the system by Siemens, the system should not be affected by the problem described by the ELEKTA manufacturer.
  • Reason
    Mosaiq software maker, elekta, has identified a problem in mosaiq, related to the windows operating system and mosaiq configurations, which results in displaying incorrect decimal symbols and / or unintentional modification of numeric data that are 10 (multiplication by 10, 100, 1000, etc.). there may also be inconsistencies in date and time formats. this problem occurs when an optional language override parameter is set in mosaiq and the language you have has a different decimal symbol than the one defined in the windows control panel settings for region and language. for example, a user may wish to select their native language (german) for text, but keep the windows operating system in english (so, in this case, all numerical data should behave according to the settings from windows to english) ). most areas of mosaiq can correctly read the windows region formats; however, some other areas treat the language overlay as a general locale overlay, which affects numeric, date, and time formats. that is the source of the problem. language overlay should not overlap numeric, date, and time formats in any case. the problem can be avoided by not selecting the "runtime language" override option.
  • Action
    The company guides you to verify that the optional language replacement parameter is set in MOSAIQ and recommends contacting Siemens Healthcare for assistance.

Device

LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Number: 100041.

Manufacturer

Siemens Ltda.; Siemens AG ; Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA