Events

Brilliance 64 Computed Tomography Xray Systems, 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
    73961
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1872-2016
  • 사례 시작날짜
    2016-04-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145692
  • 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 firm became aware of a problem where the system may not map varian drive after ct user logout/login.
  • 조치
    The firm sent a Customer Information letters dated March 8, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Device

Brilliance 64 Computed Tomography Xray Systems,
  • 모델명 / 제조번호(시리얼번호)
    Model No. 728231; S/N: 4001 5169 9056 9074 9099 9134 9251 9515 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9600 9618 9625 9631 9638 9646 9653 9656 9659 9667 9670 9678 9686 9689 9703 9711 9738 9740 9755 9763 9782 9805 9811 9822 9833 9837 9838 9859 9862 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9983 9989 9993 10012 10014 10021 10024 10042 10047 10050 10051 10077 10092 10099 10106 10150 10179 10180 10193 10206 10208 10213 10216 10250 10299 10302 10379 10394 10422 10446 10470 10514 10610 10671 10698 10743 29002 29014 29015 29056 29107 29115 90124 90154 91003 95022 95024 95130 95157 95191 95197 95213 95222 95236 95239 95244 95258 95261 95343 95349 95351 95364 95374 95387 95399 95409 95410 95439 95475 95496 95504 95507 95512 95524 95538 95551 95563 95614 95616 95668 95688 95691 95707 95811 122856 122863 122866 122877 122902 122921 122922 122953 123070 123092 123096 123116 123117 300062 95341A
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • 제품 설명
    Brilliance 64 Computed Tomography X-ray Systems || Product Usage: || 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 Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA