Electrical Lift Table 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 IBA Dosimetry GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

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.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2015-11-27
  • 사례 출판 날짜
    2015-11-27
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: iba dosimetry gmbh electrical lift table medical device manufacturer, iba dosimetry gmbh, has issued a medical device safety alert concerning its electrical lift table [part number: ha03-000#002, ha03-010#002]. the manufacturer has identified a potential safety issue that may affect the performance of the electrical lift table under certain circumstances. when the lifting table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner. due to the forces involved, a person trying to stop the lifting table can be seriously injured. to prevent this error from occurring, users should follow the instruction in the section below until the problem is completely resolved. the manufacturer instructs affected users to take the following actions:- before receiving the replacement part: disconnect the mains power connection of the electrical lift table after setting up the table and blue phantom2. the table must not be connected to the mains power when its electrical functions are not in use for alignment. after receiving the replacement part: a new hand control including its cable will be sent when it is ready. the replacement instruction will be included in the shipment. users should immediately replace the original one upon receiving the shipment. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 november 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: IBA Dosimetry GmbH Electrical Lift Table
  • Manufacturer

Manufacturer