Events

Device Recall Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology 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
    67879
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1745-2014
  • 사례 시작날짜
    2013-12-19
  • 사례 출판 날짜
    2014-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126548
  • 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
    During internal testing, the brilliance ct big bore was found to be out of tolerance for radio frequency emissions. specifically, at the 48mhz frequency, the testing indicated the brilliance ct big bore was 3.5db uv/meter higher than the applicable iec 60601-1-2 standard specification.
  • 조치
    Philips Medical System sent an Urgent Medical Device Corrections letters dated December 10, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a field service Engineer will visit the facility to perform an Electro-Magnetic Interference (EMI) noise reduction up0date on each system. For information or support concerning contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, OptionS: Enter site ID or follow prompts).

Device

Device Recall Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology
  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT Big Bore Oncology: Model #728243; Serial #s: 7185, 7187-7189, 7191-7199, 7201,-7243, 7245-7251, 7253-7267, 7269, 7270, 7272-7297, 7299, 7300, 7302, 7304-7317, 7319-7374, 7376-7379, 7381, 7382, 7385, 7387-7389, 7391-7393, 7395, 7397-7401, 7403-7406, 7409-7429, 7431-7433, 7435-7438, 7440-7451, 7454-7457, 7459, 7462-7485, 7487-7509, 7511-7513, 7515-7519, 7521-7524, 7526-7528, 7530-7532, 7534-7537, 7539-7542, 7544, 7545, 7547, 7549-7556, 7558-7562, 7564-7566, 7568, 7569, 7573, 7574, 7577-7582, 7584, 7585, 7588-7593, 7596-7599, 7601-7603, 7605, 7608, 7609, 7611-7613, 7615-7618, 7620, 7622-7624, 7626-7630, 7634, 7635, 7637-7648 & 75000.  Brilliance CT Big Bore Radiology: Model #728244; Serial #s: 7190, 7200, 7244, 7252, 7268, 7271, 7301, 7318, 7375, 7380, 7383, 7384, 7386, 7390, 7396, 7402, 7407, 7408, 7427, 7430, 7439, 7452, 7453, 7458, 7486, 7510, 7514, 7520, 7525, 7529, 7533, 7538, 7543, 7546, 7557, 7570-7572, 7575, 7576, 7583, 7586, 7587, 7595, 7600, 7604, 7607, 7610, 7614, 7619, 7621, 7625, 7631-7633 & 7636.
  • 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, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. and countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, France, French Polynesia, Gabon, Germany, India, Indonesia, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Oman, Palestine, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Ukraine & United Kingdom.
  • 제품 설명
    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. || Product Usage: || The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images 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