Events

MX8000 IDT 16 Slice CT Scanner 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00747-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00747-1
  • 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
    The ct system phantom supplied with the affected scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon.The lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use (ifu) manual. this manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable.This pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates, the test becomes unreliable and inaccurate.
  • 조치
    The customer letter is providing a guideline to a more reliable check of the image noise on the water layer of the system phantom to assure that LC is within the specification. The letter is an addendum to the Instructions for Use. It replaces the Image Quality Low Contrast measurement instructions found in the Instructions for Use.

Device

MX8000 IDT 16 Slice CT Scanner

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA