Events

O-Arm 1000 Surgical Imaging System (Portable, diagnostic, fluoroscopic x-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2016-RN-00965-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00965-1
  • 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
    After investigation of complaints, medtronic has determined that the o-arm 1000 system requires updates. 1.Technical information in the ifu require clarification, including specifications for x-ray technique factor accuracy, filtration strength, leakage technique factors, air kerma reference location, and tube housing cooling curves.2. radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply.3. the x-ray technique factor display accuracy related to ma and mas do not comply.4. x-ray generator and motion batteries require inspection to insure they are not damaged.Items 1 & 2 do not affect the safety or performance of the system. item 3 could affect performance related to image quality. item 4 addresses possible shipping damage to the batteries. damaged batteries may result in odours/fumes, smoke, and the system not functioning as intended.
  • 조치
    Medtronic is providing users with updated errata sheets with the correct information and following this up with an update to the system software that corrects this information in the on-system Instructions for Use. In addition, Medtronic will be performing the appropriate measurements of air kerma rate, as well as testing the x-ray technique factor display accuracy for compliance. A visual and electrical inspection of the batteries will also be undertaken for any potential damage.

Device

O-Arm 1000 Surgical Imaging System (Portable, diagnostic, fluoroscopic x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    O-Arm 1000 Surgical Imaging System (Portable, diagnostic, fluoroscopic x-ray system)Model Numbers: B1-700-00027, BI-700-00028ARTG Number: 135566
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA