Events

Janus and Janus G3 Automated Workstation 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 PerkinElmer 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-01032-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-08-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01032-1
  • 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
    Perkinelmer have become aware that janus and janus g3 automated workstations were failing production final acceptance testing due to a ‘horizontal motion error’ message displayed on the system. further investigation concluded that two printed circuit boards (pcb) used in mdt models of janus and janus g3 were manufactured with the incorrect resistor values. this anomaly affects component part number 7101640 (pcb-quad motor controller mdt) and part number 7101647 (pcb-quad motor controller gripper). this anomaly could result in the ‘horizontal motion error’ being displayed and result in instrument down time. the affected printed circuit boards control functional movement of the instrument head and gripper. impact to any user samples is low, as the instrument clearly displays an error message, ‘horizontal motion error’.Perkinelmer field service personnel have been instructed to schedule a customer service visit to upgrade affected customer systems with revised printed circuit boards.
  • 조치
    PerkinElmer is requesting customers: 1. Be aware that there is potential for the ‘Horizontal Motion Error’ message to display which could result in instrument down time; 2. Follow guidance provided in the Janus Automated Workstation User Manual when the ‘Horizontal Motion Error’ message displays; and 3. If you have additional questions, contact PerkinElmer Technical Support for further assistance.

Device

Janus and Janus G3 Automated Workstation
  • 모델명 / 제조번호(시리얼번호)
    Janus and Janus G3 Automated WorkstationProduct Numbers: AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001ARTG Number: 210712
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer