Department of Health에 따르면, 해당 안전성 경고 는
Hong Kong
에서 Elekta Ltd 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.
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
Field safety notice: elekta xvi 4.5 and 4.6
medical device supplier, elekta ltd, issued an important notice to bring users attention to certain precautionary measures required for the operation of elekta xvi.
xvi dual registration can inform customers if an organ at risk has moved in relation to the target since the planning stage of treatment. it was discovered at customer site that there is a software error leading to compromise of the dual registration, and this issue applies to release 4.5 and 4.6.
an important notice a357 was sent out to all xvi 4.5 and 4.6 users. the notice informs customers using dual registration with compromise how to recognize the issue and avoid it. a later software release of xvi will give a solution to this problem.
according to the local supplier, the affected products have been distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.