Events

Device Recall Brilliance Big Bore 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
    60977
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0946-2012
  • 사례 시작날짜
    2011-12-13
  • 사례 출판 날짜
    2012-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106956
  • 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 block and multi leaf collimator (mlc) shape is not propagated to the beam that is modified by the oppose operation. the contours can appear with the incorrect color in the beam's eye view viewer, resulting in organs being incorrectly placed or incorrectly shaped.
  • 조치
    On 12/13/2011, the firm sent Field Safety Notices, entitled URGENT - Medical Device Correction, to their customers. The letter identified the affected product, the problem, the hazard involved, and the actions to be taken by customers and the firm. Customers were to follow the instructions provided in order to address or avoid the issues. Philips will be installing a software update to address the identified issues free of charge. If customers need further information or support in regards to these issues, they are to contact their local Philips representative or local Philips Healthcare office. In North America and Canada, customers can contact the Customer Care Solutions Center at 1-800-722-9377.

Device

Device Recall Brilliance Big Bore
  • 모델명 / 제조번호(시리얼번호)
    Model # 728243, Serial # 7006, 7009, 7060, 7068, 7081, 7095, 7122, 7127, 7133, 7150, 7154, 7185, 7233, 7245, 7278, 7285, 7298, 7337, 7395, 7400, 7450, 7465, 7468, 7506, 7518, 7520, 7521, 7523, 7524, 7528, 7545, 7547, 7560, 7568, 7569, 7573, 7578, 7581, 7584, 7591, 7593, 7597-7599, 7602, 7611, 7616, 7617, 7618, 7620, 7622-7635, 7637-7650, 7652, 7655-7659, 7661-7663, 7665-7667, 7671-7675, 7677-7682, 7684-7687, 7689-7691, 7693, 7695, 7696, 7698-7707, & 75000.  Model # 728244, Serial # 7543, 7571, 7600, 7619, 7621, 7636, 7651, 7653, 7654, 7660, 7668-7670, 7676, 7683, 7688, 7694, 7697, 7708, & 7710.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NM, NY, OH, OR, PA, PR, TN, TX, VA, & WA and countries of AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, DOMINICAN REPUBLIC, FRANCE, GABON, GERMANY, HUNGARY, ISRAEL, ITALY, JORDAN, LUXEMBOURG, MALI, MEXICO, NETHERLANDS, OMAN, SLOVAKIA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UKRAINE, UNITED ARAB EMIRATES, & UNITED KINGDOM.
  • 제품 설명
    Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. || Computed Tomography X-Ray System intended to produce 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