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.
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Medical Device Safety Alert
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Field safety notice: tomotherapy treatment systems hi‧art versions 4.0.X, and hd versions 1.0.X
tomotherapy has issued a field safety notice to customers of tomotherapy treatment systems with hi·art versions 4.0.X, and hd versions 1.0.X. there is an anomaly in the software, in which during dicom export of plan level images with a non square exported field of view, an anomaly in the process of squaring the plan level image may cause the image to shift with respect to rois and dose.
according to the local supplier, the affected products are available in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.