Events

Device Recall Brilliance 64 and Ingenuity Computed Tomography (CT) 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
    63817
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0674-2013
  • 사례 시작날짜
    2012-12-03
  • 사례 출판 날짜
    2013-01-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114827
  • 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
    Software anomalies. philips medical systems recalled their brilliance 64 running software v4.0.0xx516 and their ingenuity ct running software v4.0.0xx518 due to software issues detected in these ct scanning systems. if these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
  • 조치
    The firm, Philips Healthcare, sent an 'URGENT- Medical Device Correction" letters' dated November 15, 2012, and December 3, 2012, to their customers. Both letters describe the product, problem and actions to be taken. The letters state that Philips is notifying all affected customers of this information via a 'Field Safety Notice and will be installing a software update on the affected Brilliance 64 and Ingenuity CT system in order to address these issues. A Philips' Field Service Engineer will be contacting each customer site and make arrangements to install the necessary software update on these device systems. The customers should contact their local Philips representative or local Philips Healthcare office. In North America and Canada needing further information or support concerning this update, should contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5, and enter their site ID or follow the prompts.

Device

Device Recall Brilliance 64 and Ingenuity Computed Tomography (CT)
  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.
  • 제품 설명
    Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are 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