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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Medical device safety alert: ormco enlight unidose
medical device manufacturer, ormco corporation, is conducting a recall on one lot of enlight unidose as the result of a mispackaging error.
sybron dental specialties, inc. (sds), a company representing ormco corporation, reported that the product labeled as enlight unidose actually contained enlight syringes andthere are no safety or efficacy issues associated with this mispackaging error.
according to sdss, the affected devices were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.
posted on 17 may 2012.