Events

Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Brainlab 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-2013-RN-00716-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00716-1
  • 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
    It has been detected that the pointer cap with the engraved cross hairs may become loose even when only a moderate force is applied to the pointer cap. due to the manufacturing tolerances specified the force to loosen the pointer cap may vary, depending on the individual pointer cap and aluminium pointer rod assembly. if this occurs, most likely the pointer cap will detach completely, rendering the target pointer no longer usable. in a scenario that the pointer cap would loosen but not detach completely, a shift of the pointer cap of up to 2mm might remain unnoticed. since the device is used for calibration and quality assurance of patient positioning technologies for radiation therapy treatments at a linear accelerator, this scenario might degrade the accuracy of the positioning solution used.
  • 조치
    Brainlab is requesting users to inspect stock and quarantine affected devices. Replacement stock will be provided to affected customers.

Device

Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient posit...
  • 모델명 / 제조번호(시리얼번호)
    Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)Product Number: 43410Serial Number: 1223012002, 1223012007, 1223012008ARTG Number: 121226
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd