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.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
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The importer reports that the diameters of the oxygen dials have a diameter greater than normal, this accessory of the device is difficult to exchange, leading to possible delays in the procedures or adverse events on patients.
This sanitary registry covers the models HX.O01, HXO02, HX.O04 in sizes XXL, XL, L, M, S, XS. Associated labels conradicated no. 2017031444 of March 08, 2017 with updated and additional information. Authorization of labels in the sense of updating in the field of "color of the diluent" the distribution of the colors that is found on the label of the mask for oxygen supply ventury, by means of 2017121480