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.
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
There is a possibility that improper handling may occur due to incorrect positioning of the patient: if the coordinate structure is not locked correctly to the Frame Adapter, a gap can be created and possibly the target of the planned position can be shifted by up to 0.5mm . Check the Important Field Safety Notice issued by Elekta. The company reported that there are two equipment under risk in Brazil.
원인
Possible misalignment of the frame adapter structure of the device.
조치
Verify instructions in the Important Field Safety Notice, at http://portal.anvisa.gov.br/wps/wcm/connect/402cca0045ea2ca69a27be7ffa9843d8/Assessment+Important+of+Security+-+ELEKTA.pdf?MOD= AJPERES