Events

Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2014-RN-01113-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01113-1
  • 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
    Siemens has received reports of unintended radial motion of the detectors. this unintended motionmay cause the patient, compression related injuries. the symbia s or t system has been designed to detect such faults and automatically shut down. if the system shuts down with the message "system requires service, please contact your customer service representative" the system will be disabled until the error is manually cleared during service there have been no reports of injury as a result of this potential motion.
  • 조치
    A Siemens local service engineer will contact customers to perform the inspection and schedule any necessary repairs to the affected systems. Siemens is advising that while waiting for the inspection to be performed, customers can continue to use their systems by adhering to the Cautions and Warnings in the user's manual and observing the patients during studies. This action has been closed-out on 08/08/2016.

Device

Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)
  • 모델명 / 제조번호(시리얼번호)
    Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)Catalogue numbers: 8717733, 8717741, 10275007, 10275008, 10275009 & 10275010ARTG numbers: 123883 & 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd