Device Recall Brilliance CT 6slice,16slice, 40channel, 64channel,Big Bore Oncology & Brilliance iCT and iCT SP 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
    62498
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2035-2012
  • 사례 시작날짜
    2012-07-02
  • 사례 출판 날짜
    2012-07-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Philips healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their brilliant ct scanner have been found to be defective and the bolt heads may break off.
  • 조치
    Philips sent a Urgent Medical Device Correction letter dated June 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will visit each site to inspect and correct the issue, and Philips will be tracking the progressof the correction. For further information, Customers were asked to contact their local Philips representative or Philips Healthcare Office. North American and Canadian consignees should contact the Philips Customer Care Solutions Center at 1-800-722-9377

Device

  • 모델명 / 제조번호(시리얼번호)
    Brilliance 64, M/N #728231, Serial #s,  10140, 10141,10142, 10143, 10144, 10145, 10146, 10147, 10148, 10149, 10150, 10151, 10152,10153, 10154, 10155, 10156, 10157, 10158, 10159, 10160, 10161, 10162, 10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10189, 10190, 10191, 10192, 10193, 10194, 10195, 10196, 10197, 10198, 10200, 10203, 10204, 10206, 10207, 10208, 10209, 10210, 10211, 10213, 10216, 10218, 10221, 10222, 10223, 10224, 10225, 10226, 10229, 10230, 10232, 10233, 10234, 10237, 10238, 10239, 10241, 10242, 10243, 10244, 10245, 10247, 10248, 10249, 10250, 10252, 10255, 10256, 10257, 10258, 10259, 10260, 10262, 10263, 10264, 10266, 10267, 10268, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300 Brilliance 40, M/N #728235, Serial #s  9258, 9259, 9260, 9261, 9262, 9263, 9264, 9265, 9266, 9267, 9268 Brilliance Big Bore, M/N #728243 Serial #s 7445, 7446, 7447, 7448, 7449, 7450, 7451, 7454, 7455, 7456, 7457, 7459, 7462, 7463, 7464, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7487, 7488, 7489, 7490, 7491, 7492, 7493, 7494, 7495, 7496, 7497, 7498, 7499, 7500, 7501, 7502, 7503, 7504, 7505, 7506, 7507, 7508, 7509, 7511, 7512, 7513  Brilliance Big Bore, M/N #728244 Serial #s 7452, 7453, 7458, 7486, 7510, 7514 Brilliance 16, M/N #728246 Serial #s 5990, 5991, 5992, 5993, 5994, 5995, 5996, 5997, 5998, 5999, 6000, 6001, 6002, 6003, 6004, 6005, 6006, 6007, 6008, 6009, 6010, 6011, 6012, 6013, 6014, 6015, 6016, 6017, 6018, 6020, 6021, 6022, 6023, 6024, 6025, 6026, 6027, 6028, 6029, 6030, 6031, 6032, 6033, 6034, 6035, 6036, 6037, 6038, 6039, 6040, 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6055, 6056, 6058, 6059, 6060, 6061, 6062, 6063, 6064, 6065, 6066, 6067, 6068, 6069, 6070, 6071, 6072, 6073, 6074, 6075, 6076, 6077, 6078, 6079, 6080, 6081, 6082, 6083, 6084, 6085, 6086, 6087, 6088, 6089, 6090, 6091, 6092, 6093, 6094, 6095, 6096, 6097, 6098, 6099, 6100, 6101, 6102, 6104, 6105, 6106, 6107, 6108, 6109, 6110, 6111, 6112, 6113, 6114, 6115, 6117, 6118, 6119, 6120, 6121, 6122, 6123, 6124, 6125, 6126, 6127, 6128, 6129, 6130, 6131, 6132, 6133, 6134, 6135, 6136, 6137, 6138, 6139, 6140, 6141, 6142, 6143, 6144, 6145, 6146, 6147, 6148, 6149, 6150, 6151, 6152, 6153, 6154, 6155, 6156, 6157, 6158, 6159, 6160, 6163, 6165, 6166, 6167, 6168, 6169, 6170, 6171, 6172, 6173, 6174, 6175, 6176  Brilliance 6, M/N #728256 Serial # 3669, 3670, 3671, 3672, 3673, 3674, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3682, 3683, 3684, 3685, 3686, 3687, 3688, 3689, 3690, 3691, 3692, 3693, 3694, 3695, 3696, 3697, 3698, 3699, 3700, 3701, 3702, 3703, 3704, 3705, 3706, 3707, 3708, 3709 Brilliance iCT, M/N #728306 Serial #s 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100155, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170  Brilliance iCT SP, M/N #728311 Serial #s 200006, 200007, 200008, 200009, 200010, 200011, 200012, 200013, 200015, 200016, 200017, 200018, 200019, 200020, 200021, 200022, 200023, 200024, 200025, 200026, 200027, 200028, 200029, 200030, 200031, 200032, 200033, 200034, 200035, 200036, 200037, 200038
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, MJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, VT, and WI. and the countries of Canada, Argentina, Australia, Austria, Azerbaijan, Brazil, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Iceland, India, Indonesia, Iraq, Italy, Jordan, Kazakhstan, Kazakhstan, Libyan Arab Jamahiriya, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Palestine, Peru, Philipines, Poland, Portugal, Russia, Russia Fed, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
  • 제품 설명
    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. || The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
  • Manufacturer

Manufacturer

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