Events

Pinnacle3 software 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Philips Healthcare 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
  • 날짜
    2013-05-08
  • 사례 출판 날짜
    2013-05-08
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508c.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: philips pinnacle3 software medical device manufacturer, philips healthcare issued a field safety notice concerning all pinnacle3 software with versions 9, 9.2, and 9.4. a problem has been detected in the philips pinnacle3 software that, if it were to re-occur, could affect the performance of the equipment. under certain conditions in pinnacle3 9, 9.2, and 9.4, users can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose. philips healthcare is distributing an addendum to the pinnacle3 instructions for use (ifu) which describes how to explicitly invalidate control point dose in this situation. the underlying issue is corrected in pinnacle3 9.6. the manufacturer recommends customers to review the information contained in the notice including the ifu addendum with all members of the staff who need to be aware of their contents and retain a copy of the addendum with the pinnacle3 9, 9.2, and 9.4 ifu. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Pinnacle3 software
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Philips Pinnacle3 software
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • 제조사 모회사 (2017)
    Philips
  • Source
    DH