FUJIFILM Digital Mammography System AMULET f/s(FDR MS-2500/2000), AMULET Innovality(FDR MS-3500)
에 대한 현장 안전성 서한
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 FUJIFILM 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
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.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
데이터 추가 비고
원인
There was a case that the swivel arm went down unintentionally when it was moved up/down.
based on the investigation result, it has been determined that the possibility of occurrence in
other devices is very low. however, in order to further enhance the safety, improvement is made
as a voluntary field correction to prevent the swivel arm from going down unintentionally in all the
devices having the same structure.
while the probability that a problem occurs is very rare; fujifilm wishes to reduce any potential
risk to patients as soon as possible.