Events

GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia 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-2015-RN-00924-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-09-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00924-1
  • 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
    Ge has recently become aware of a potential safety issue with performing head or neck scans on the affected scanners. the currently displayed specific absorption rate (sar) values could be lower than the actual sar in the head and neck as predicted by sar modelling. the predicted head sar value from the modelling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.When the system transmits rf power using the whole body rf transmit coil, the sar value displayed on the system user interface, will be shown as equal to the whole body sar; therefore the sar delivered to the head could be higher than the displayed sar value. if patients receive higher than expected radio-frequency (rf) energy absorbed during mr imaging procedures, specifically for patients with mr conditional implants, then localised deep-tissue heating or thermal injury in the vicinity of implants could occur. there have been no injuries identified as a result of this issue.
  • 조치
    GE Healthcare will correct all affected products. In the interim, for patients with MR conditional head and neck implants, customers are advised to use only the transmit/receive HEAD coil for conducting head and neck scans and to follow the implant’s labelling and instructions strictly. Also, do not scan patients with implants that have been labelled as MR Conditional with HEAD SAR requirements other than the IEC limit for 3.2 W/kg, as stated in the MR operator manual. For all patients, limit the length of scan protocols; specifically, do not scan any patient continuously without any break for longer than 100 minutes. As is the case for all MR imaging, follow Good Clinical Practices. This action has been closed-out on 07/09/2016.

Device

GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/...
  • 모델명 / 제조번호(시리얼번호)
    GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T ARTG Number: 223115
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd