uninterruptable power supply batteries used with philips ct and molecular imaging systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Philips 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
    2015-03-24
  • 사례 출판 날짜
    2015-03-24
  • 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: uninterruptable power supply (ups) batteries used with philips ct and molecular imaging systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning uninterruptable power supply (ups) batteries used with philips computed tomography and molecular imaging systems. the manufacturer has become aware of ups device failures that resulted in leaking of electrolyte (sulfuric acid), overheating and/or emission of fumes. analysis has identified that these failures are most likely due to batteries within the ups devices being held in service beyond their usable service life – typically three to five years. hazards involved as a result of ups devices failing include chemical burn, thermal burn and eye, nose and/or throat irritation. the manufacturer advises users to review the accompanying material and implement a ups maintenance programme at their facility as recommended by the manufacturer of their ups. to ensure continued safe and reliable performance from these devices, periodic maintenance is required - including possible battery replacement. the manufacturer has provided a ups information flyer outlining maintenance needs and a suggested maintenance strategy. according to philips healthcare, the concerned ups batteries are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 march 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Uninterruptable Power Supply (UPS) Batteries used with Philips CT and Molecular Imaging Systems
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DH