Events

Brilliance 64, Brilliance Big Bore, Brilliance iCT, Brilliance iCT SP, Ingenuity 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
    60873
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0845-2012
  • 사례 시작날짜
    2011-10-07
  • 사례 출판 날짜
    2012-01-24
  • 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=106694
  • 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
    The common image reconstruction system (cirs) on the affected brilliance systems encounters an error and requires reboot of the system. the unit failed to initialize axial scan due to timeout that occurred waiting for "ready" state.
  • 조치
    On 10/10/2011 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected products, the problem, the hazard involved, the action to be taken by the customer, and actions planned by Philips. Customers were to reboot their systems if the two possible scenarios occurred. Philips Healthcare plans on installing the update through a Field Change Order free of charge. For further information or support concerning the issue, contact a local Philips representative or local Philips Healthcare office. In North America and Canada, contact Customer Care Solutions Center at 1-800-722-9377, option 5.

Device

Brilliance 64, Brilliance Big Bore, Brilliance iCT, Brilliance iCT SP, Ingenuity CT
  • 모델명 / 제조번호(시리얼번호)
    Model #'s - Brilliance 64: 728231, Ingenuity CT: 728326, iCT: 728306; iCT SP: 728311 & Brilliance Big Bore: 728243
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of: AL, AZ, CA, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA & WV and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BANGLADESH, BELGIUM, Brazil, CHINA, COLUMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LUXEMBOURG, MALAYSIA, MALI, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, QATAR, RUSSIA, SINGAPORE, SLOVENIA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN & VIETNAM.
  • 제품 설명
    Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland, OH. || Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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