Events

ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board) 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-2013-RN-00325-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00325-1
  • 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
    When using the v5m transducer, the display of the temperature on the acuson sc2000 system can be lower than the actual temperature of the v5m transducer. this occurs only if the system hardware contains revision 4 of the mpi board. if this condition occurs when scanning a febrile or hyperthermic patient using maximum system power settings (0 db), the actual lens surface temperature could exceed 43degc while the system temperature display continues to show a value under 43degc. there is a potential to cause oesophageal burns in patients with body temperatures greater than 40degc.Products supplied in australia include a different transducer (4z1c) which cannot be used for trans-oesophageal imaging. potential for heating with this model is mitigated by independent mechanical cooling which is not dependent on a feedback mechanism. siemens is correcting all models including revision 4 of the mpi board irrespective of the transducer version.
  • 조치
    Siemens is providing temporary work around instructions and is implementing an upgrade of the system hardware that will correct the issue.

Device

ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (wh...
  • 모델명 / 제조번호(시리얼번호)
    ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board)ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd