Events

Device Recall Philips Healthcare Brilliance 64 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) Inc 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
    79759
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1396-2018
  • 사례 시작날짜
    2018-02-21
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163255
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, x-ray, tomography, computed - Product Code JAK
  • 원인
    Surview scan with tube current lower than 30 ma is unable to be initialized.
  • 조치
    On February 21, 2018 Philips Medical Systems sent a Customer Information Letter regarding the Philips Brilliance 64 Software Model 4.1.7. Customers were informed of how to identify affected products and instructed to use the Instructions For Use recommended 30mA for surview scans. Customers with questions or concerns should contact their local Philips representative or local Philips Healthcare office Customer Care Solutions Center at 1-800- 722-9377.

Device

Device Recall Philips Healthcare Brilliance 64
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
  • 제품 설명
    Brilliance 64 with 4.1.7 XX026 software version model number 728231 || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA