Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01098-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-23
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    There is the potential for a short circuit between the pcb (printed circuit board) and heater transistor or a malfunction of the transistor with the sysmex cs-5100. this may lead to smoke from the instrument, and in a worst case scenario, the overcurrent damaging the pcb, which may lead to a melting of the transistors until the instrument is powered off. this failure mode will occur if all of the conditions below are met:- pcb protection component blocks overcurrent by the short circuit- pcb protection component has a breakdown after a certain period with the instrument turned on- the overcurrent is throughout the pcb, which may lead to burn out unless the instrument is powered off.
  • 조치
    Follow the instructions provided by Sysmex and confirm receipt of the information issued in August 2017. Complete and return the Response Form attached to the customer letter by Friday 22nd of September 2017. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files and forward this information to all parties that may use a Sysmex CS-5100 system. A Siemens field service representative will visit and disconnect the connector on the PCB.

Device

  • 모델명 / 제조번호(시리얼번호)
    Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10709128Serial Numbers before 24425ARTG Number: 179939
  • Manufacturer

Manufacturer