Device Recall Various Brilliance and Ingenuity systems, see below 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
    69969
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0979-2015
  • 사례 시작날짜
    2014-12-08
  • 사례 출판 날짜
    2015-01-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-10-01
  • 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
    Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
  • 조치
    Philips sent an Urgent - Field Safety Notice letter dated December 4, 2014 to all affected customers. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will service the system to resolve the issue. For questions contact your local Philips representative or local Philips Healthcare office.

Device

  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT 16 Air: Model Number 728246:  Serial Numbers: 3117,6680,6692,6693,6697,6698,6700,6703,6706,6707,6708,6709,6711,6712,6713, 6715,6716,6718,6719,6720,6721,6722,6723,6724,6726,6727,6728,6729,6730,6731, 6732,6734,6735,6736,6737,6738,6740,6742,6743,6744,6746,6747,6748,6749,6750, 6751,6752,6753,6754,6755,6756,6757,6759,6760,6761,6762,6764,6765,6766,6767, 6769,6770,6771,6772,6774,6775,6778,6779,6783,6784,50209,50213,50215,50216, 50217,50221,50222,50223,50224,50225,50226,50227,260013,260015,260016, 260017,260018,260025,260027,260028,260029,260030,260032,260035,260042, 260043,260045,260046,270002,270003,270004,270005,270006  Brilliance CT 64: Model Number 728231: Serial Numbers: 10773,10793,10795,10798,10803,10805,95061,95857,95861,95865,95880,95881, 95882,95883,95885,95892,95895,95900,95908,95909,95910,95912,95915,95916, 95918,95920,95921,95922,95924,95925,95926,95928,95930,95933,95936,95944  Brilliance CT Big Bore Oncology: Model Number 728243: Serial Numbers: 7884,7890,7909,7923,7925,7927,7928,7929,7936,7938,7940,7941,7942,7944,7945, 7948,7949,7955,7956,7963,7968,7969,7970,7971,7973,7975,7976,7977,7980,7984, 7989,7990,7991,7994,7995,7996,7999,8002,8005,8006  Brilliance CT Big Bore Radiology: 728244 Serial Numbers: 7879,7897,7912,7919,7922,7926,7930,7943,7957,7958,7959,7967,7979,7985,7988, 7992  Brilliance iCT: Model Number 728306: Serial Numbers: 10065,100428,100432,100445,100450,100451,100452,100454,100455,100460, 100463,100465,100466,100470,100471,100474,100475,100476,100477,100478, 100479,100480,100481,100483,100485,100486,100487,100488,100489,100490, 100491,100492,100493,100494,100496,100498,100499,100500,100502,100503, 100504,100505,100507,100508,100509,100510,100514,100515,100517,100520  Brilliance iCT SP: Model Number 728311: Serial Numbers: 200126,200131,200137,200138  Ingenuity CT: Model Number 728326: Serial Numbers: 30005,30006,30009,30011,30012,30013,30014,30015,91007,300022,300028,300032,300035,300036,300156,300157,300158,300161,300162,300164,300165,300166, 310170  Ingenuity Core: Model Number 728321: Serial Numbers: 31001,52001,52002,52003,52004,52006,52007,52009,52010,52011,52013,52015, 52016,52017,52018,52020,52021,52024,52026,52030,52031,52032,52033,310032, 310090,310113,310114,310115,310116,310121,310129,310131,310134,310135, 310137,310138,310139,310140,310144,310145,310147,310148,310149,310151, 310152,310153,310154,310155,310158,310160,310161,310162,310163,310164, 310165,310170,310171,333005,333009,333011,333012,333013,333014,333015, 333016,333017,333020,333024,333026,333031,Unknown,Unknown  Ingenuity Core128: Model Number 728323: 30153,32001,32002,32003,32004,32005,32006,32007,32009,32010,32011,32012, 32013,32014,32015,32016,32018,32020,32021,32023,32024,32025,32026,32029, 32030,32031,32032,32033,32034,32035,32036,32037,32038,32040,32041,32042, 32043,32044,32046,32047,32048,32049,32051,32052,32054,32062,32064,32065, 32066,32067,32068,32069,32070,320022,320097,320101,320102,320105,320106, 320107,320109,320112,320113,320114,320116,320117,320118,320120,320121, 320122,320124,320125,320126,320128,320129,320131,320134,320137,320138, 320139,320140,320141,320142,320143,320144,320145,320146,320147,320148, 320150,336001,336002,336006,336007,336008,336009,336010,336011,336012, 336013,336014,336015,336016,336018,336020,336021,336024,336025,336026, 336027,336028,336029,336030,336031,336032,336033,336034,336035,336036, 336037,336038,336039,336040,336042,336043,336044,336046,336047,336048, 336050,336051,336052,336055,336056,336057,336064,336072  Ingenuity Flex: Model Number 728317: 260002,260003,340002,345001,345002,345003,345004,345005,345006,345007, 345010,345012,345013,345014,345016,345017,345018,345022,345024
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government consignee. The affected product was also distributed to the following foreign countries: Canada, Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Cayman Islands, China, Czech Republic, Denmark, Ecuador, Ethiopia, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Libyan Arab Jamahiriya, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, United Kingdom, and Vietnam.
  • 제품 설명
    Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package || 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
  • Source
    USFDA