Events

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

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Ltda.; Siemens AG ; Siemens Medical Solutions USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1677
  • 날짜
    2015-08-27
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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.