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.
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원인
During testing, trumpf medical found that the radiated emissions from the truvidia ™ wireless receiver exceeded the regulatory limits. it is unlikely, but it is possible that the radiated emissions will affect other devices in the operating room, which could cause other devices to malfunction. the frequency of interference and associated risks will depend on the immunity of other devices to the emitted emissions and the nature of the equipment error in the operating room used at that time. trumpf medical has not received any complaints or allegations of injuries related to the issue.