Events

Multidata Radiotherapy Decision Planning Support Systems. All Product Codes 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Multidata Systems Internacional Corp 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
    263
  • 날짜
    2001-11-28
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    In the older versions of the software for the radiotherapy systems, there was acceptance of inappropriately inserted blocks in a different way than was specified in the user manual. when a block is inserted improperly, the software can calculate an unexpected overdose of radiation that may go unnoticed by the user and cause harm to the patient. the manufacturer initiated a voluntary correction work through a letter dated 12.09.01 and sent all customers a software maintenance and maintenance package with a support system entitled project safeguard, which consists of a modified version of the block scanning program.
  • 조치
    Make sure you have received the letter and the package with Project Safeguar. Install the updated Maintenance Pack as instructed on the diskette label. This should take about 35 seconds. A filter that rejects an unacceptable block is included in the modified version of the block scan program. This maintenance update is only a specific upgrade to the block scanning program and will not affect the performance or any other function or configuration of the treatment planning system. For more information, and to notify Multidata's helpdesk after receiving the update package, contact Multidata via telephone in the USA at 1 (314) 968-1001 or 1 (314) 968-6443, or by email: helpdesk@multidata-systems.com.

Device

Multidata Radiotherapy Decision Planning Support Systems. All Product Codes

Manufacturer

Multidata Systems Internacional Corp
  • Source
    ANVSANVISA