Drytec Tc-99m Generator Lot number 5666 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 GE Healthcare 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
    2009-04-23
  • 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
    Press release
  • 원인
    Voluntary recall of device containing non-sterile radioactive material the department of health (dh) received notification from a medical device manufacturing company about its voluntary recall of a batch of radiodiagnostic device which has failed the sterility test. according to the company- uk ge healthcare, the involved batch was known as drytec tc-99m generator lot number 5666. there was a possibility of infection if the non-sterile product was injected into patients. the device is used to prepare radioactive material for injection to patients during radiodiagnostic procedures. information available showed that the affected lot had been used in tuen mun hospital and hong kong sanatorium and hospital. so far, no adverse effect associated with the use of device has been received by dh. the dh has informed the hospital authority, private hospitals, radiodiagnostic laboratories and medical professional associations about the recall and advised them to check for details with the company. dh will continue to monitor the situation and advise the public and health profession accordingly. ends/wednesday, april 23, 2008.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Voluntary recall of device containing non-sterile radioactive material
  • Manufacturer

Manufacturer