현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 Sweden.
데이터 추가 비고
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조치
The product is a ventouse for obstetric use. Products that have been delivered between 26/10 2010 and 8/6 2011 has been found to be tainted with an error, which could mean that there will be a vacuum in the product. The affected product series has been revoked 29/6 2011. For more information, contact the manufacturer via email tom.williams@coopersurgical.com.