Philips Healthcare MX 16slice CT Scanner System and MX 16slice CT Scanner System Phase 11 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
    69473
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0190-2015
  • 사례 시작날짜
    2014-10-09
  • 사례 출판 날짜
    2014-12-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-02
  • 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
    "the orientation of images is displayed incorrectly. when operator chooses gantry on the right side from operation console, and the patient position is hfdl, hfdr, ffdl or ffdr, the patient position picture and text is not consistent. "l" and "r" of scan images are reversed and this is not consistent with the patient actual position. "when a surview which is longe.
  • 조치
    Philips is informing the consignees of this issue through a Field Safety Notice (FSN) 72800615 on October 09, 2014. 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 contact each site to schedule a time to install the software update.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Number: 728131, Serial Number(s):  EP16E090001,EP16E090002,EP16E090003,EP16E090004,EP16E090006,EP16E090007,EP16E090008, EP16E090009,EP16E090010,EP16E090011,EP16E090012,EP16E090013,EP16E090015,EP16E100001, EP16E100004,EP16E100005,EP16E100006,EP16E100007,EP16E100008,EP16E100010,EP16E100011, EP16E100012,EP16E100013,EP16E100015,EP16E100016,EP16E100017,EP16E100018, EP16E100019,EP16E100020,EP16E100021,EP16E100022,EP16E100023,EP16E100024,EP16E100025, EP16E100026,EP16E100027,EP16E100028,EP16E100029,EP16E100030,EP16E100031,EP16E100032, EP16E100033,EP16E100034,EP16E100035,EP16E100036,EP16E100037,EP16E100038,EP16E100039, EP16E100041,EP16E100043,EP16E100044,EP16E100045,EP16E100046,EP16E100047,EP16E100048, EP16E100049,EP16E100051,EP16E100052,EP16E100055,EP16E100056,EP16E100057,EP16E100058, EP16E100059,EP16E100060,EP16E100061,EP16E100062,EP16E100063,EP16E100067,EP16E100069, EP16E100070,EP16E100071,EP16E100072,EP16E100073,EP16E100074,EP16E100075,EP16E100076, EP16E100077,EP16E100078,EP16E100079,EP16E100080,EP16E100081,EP16E100082,EP16E100083, EP16E100084,EP16E100085,EP16E100086,EP16E100087,EP16E100088,EP16E100090,EP16E100091, EP16E100092,EP16E100093,EP16E100094,EP16E100095,EP16E100096,EP16E100099,EP16E100100, EP16E100101,EP16E100102,EP16E100103,EP16E100104,EP16E100105,EP16E100106,EP16E100107, EP16E100108,EP16E100109,EP16E100110,EP16E100111,EP16E100112,EP16E100113,EP16E110003, EP16E110005,EP16E110006,EP16E110007,EP16E110009,EP16E110011,EP16E110012,EP16E110013, EP16E110014,EP16E110015,EP16E110017,EP16E110018,EP16E110019,EP16E110020,EP16E110021, EP16E110023,EP16E110024,EP16E110025,EP16E110026,EP16E110027,EP16E110028,EP16E110029, EP16E110030,EP16E110031,EP16E110032,EP16E110033,EP16E110034,EP16E110035,EP16E110037, EP16E110038,EP16E110039,EP16E110042,EP16E110043,EP16E110044,EP16E110045,EP16E110046, EP16E110047,EP16E110048,EP16E110049,EP16E110050,EP16E110051,EP16E110052,EP16E110054, EP16E110055,EP16E110056,EP16E110057,EP16E110058,EP16E110060,EP16E110062,EP16E110063, EP16E110064,EP16E110066,EP16E110067,EP16E110069,EP16E110070,EP16E110074,EP16E110075, EP16E110077,EP16E110078,EP16E110083,EP16E110085,EP16E110089,EP16E110090,EP16E110091, EP16E110092,EP16E110093,EP16E110095,EP16E110096,EP16E110097,EP16E110099,EP16E110100, EP16E110101,EP16E110102,EP16E110104,EP16E110105,EP16E110106,EP16E110108,EP16E110109, EP16E110110,EP16E110111,EP16E110115,EP16E110117,EP16E110118,EP16E110119,EP16E120003, EP16E120004,EP16E120005,EP16E120006,EP16E120007,EP16E120008,EP16E120009,EP16E120010, EP16E120011,EP16E120014,EP16E120015,EP16E120016,EP16E120017,EP16E120019,EP16E120021, EP16E120023,EP16E120024,EP16E120025,EP16E120026,EP16E120027,EP16E120029,EP16E120030, EP16E120031,EP16E120032,EP16E120033,EP16E120034,EP16E120035,EP16E120036,EP16E120037, EP16E120039,EP16E120041,EP16E120042,EP16E120043,EP16E120044,EP16E120045,EP16E120046, EP16E120047,EP16E120048,EP16E120050,EP16E120051,EP16E120052,EP16E120054,EP16E120055, EP16E120056,EP16E120058,EP16E120059,EP16E120060,EP16E120061,EP16E120063,EP16E120065, EP16E120067,EP16E120070,EP16E120071,EP16E120072,EP16E120074,EP16E120075,EP16E120076, EP16E120078,EP16E120081,EP16E120083,EP16E120088,EP16E120090,EP16E120091,EP16E120092, EP16E120093,EP16E120095,EP16E120096,EP16E120097,EP16E120098,EP16E120099,EP16E120100, EP16E120101,EP16E120102,EP16E120104,EP16E120105,EP16E120109,EP16E120110,EP16E120111, EP16E120113,EP16E120117,EP16E120118,EP16E120120,EP16E120121,EP16E120122,EP16E120123, EP16E120124,EP16E120125,EP16E120127,EP16E120128,EP16E120129,EP16E120130,EP16E130002, EP16E130003,EP16E130004,EP16E130005,EP16E130006,EP16E130007,EP16E130009,EP16E130010, EP16E130012,EP16E130013,EP16E130014,EP16E130015,EP16E130016,EP16E130017,EP16E130020, EP16E130021,EP16E130022,EP16E130023,EP16E130025,EP16E130026,EP16E130027,EP16E130029, EP16E130030,EP16E130031,EP16E130033,EP16E130034,EP16E130035,EP16E130036,EP16E130037, EP16E130040,EP16E130041,EP16E130042,EP16E130043,EP16E130044,EP16E130045,EP16E130046, EP16E130047,EP16E130048,EP16E130049,EP16E130050,EP16E130051,EP16E130052,EP16E130053, EP16E130055,EP16E130056,EP16E130057,EP16E130058,EP16E130062,EP16E130063,EP16E130064, EP16E130065,EP16E130066,EP16E130067,EP16E130068,EP16E130069,EP16E130070,EP16E130071, EP16E130072,EP16E130073,EP16E130074,EP16E130075,EP16E130076,EP16E130077,EP16E130078, EP16E130079,EP16E130080,EP16E130081,EP16E130082,EP16E130083,EP16E130086,EP16E130087, EP16E130088,EP16E130089,EP16E130091,EP16E130092,EP16E130093,EP16E130094,EP16E130095, EP16E130097,EP16E130098,EP16E130099,EP16E130100,EP16E130101,EP16E130102,EP16E130103, EP16E130105,EP16E130106,EP16E130107,EP16E130109,EP16E130110,EP16E140001,EP16E140002, EP16E140003,EP16E140006,EP16E140007,EP16E140008,EP16E140009,EP16E140010,EP16E140011, EP16E140012,EP16E140013,EP16E140014,EP16E140015,EP16E140016,EP16E140017,EP16E140018, EP16E140019,EP16E140021,EP16E140022,EP16E140023,EP16E140024,EP16E140025,EP16E140026, EP16E140027,EP16E140028,EP16E140029,EP16E140030,EP16E140031,EP16E140032,EP16E140033, EP16E140041,EP16EB110003,EP16EB110004,EP16EB110005,EP16EB110006,EP16EB120006, EP16EB120007, EP16EB120008, EP16EB120009, EP16EB130001, EP16EB130002, EP16EB130003, EP16EB130004, EP16EB130005, EP16EB130006, EP16EB130007, EP16EB130008, EP16EB130009, EP16EB130010, EP16EB130011, EP16EB130012, EP16EB130013, EP16EB130014, EP16EB130015, EP16EB130016, EP16EB130017, EP16EB130018, EP16EB130019, EP16EB130020, EP16EB130021, EP16EB140001, EP16EB140002, P16C080001, P16C080002, P16C100001, P16C100002, P16C100003, P16C100004, P16C100005, P16C100007, P16C100008, P16C100009, P16C100010, P16C100011, P16C100012, P16C100013, P16C100014, P16C100015, P16C100017, P16C100018, P16C110001, P16C110002, P16C110003, P16C110004, P16C110005, P16C110006, P16C110007, P16C110008, P16C110011, P16C110012, P16C110013, P16C110014, P16C110015, P16C110016, P16C110017, P16C110018, P16C110019, P16C110020, P16C110021, P16C110022, P16C110023, P16C110024, P16C110025, P16C110026, P16C110027, P16C110028, P16C110029, P16C110030, P16C110031, P16C110032, P16C110033, P16C110034, P16C110035, P16C110036, P16C110037, P16C120001, P16C120002, P16C120003, P16C120006, P16C120007, P16C120008, P16C120009, P16C120010, P16C120011, P16C120012, P16C120014, P16C120015, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120028, P16C120029, P16C120030, P16C120031, P16C120032, P16C120033, P16C120034, P16C120035, P16C120036, P16C120037, P16C120038, P16C120039, P16C120040, P16C120041, P16C120042, P16C120043, P16C120044, P16C120045, P16C120046, P16C120047, P16C120048, P16C120049, P16C120050, P16C120051, P16C130001, P16C130002, P16C130003, P16C130004, P16C130005, P16C130006, P16C130007, P16C130008, P16C130009, P16C130010, P16C130011, P16C130012, P16C130013, P16C130014, P16C130015, P16C130016, P16C130017, P16C130018, P16C130019, P16C130020, P16C130021, P16C130023, P16C130024, P16C130025, P16C130026, P16C130027, P16C130028, P16C130029, P16C130030, P16C130031, P16C130032, P16C130033, P16C130034, P16C130035, P16C130036, P16C130037, P16C130038, P16C130039, P16C130041, P16C130043, P16C130044, P16C130045, P16C130046, P16C130047, P16C130048, P16C130049, P16C130050, P16C130051, P16C130052, P16C130053, P16E080005, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090005, P16E090006, P16E090007, P16E090008, P16E090009, P16E090010, P16E090011, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090017, P16E090018, P16E090019, P16E090020, P16E090021, P16E090024, P16E090025, P16E090026, P16E090027, P16E090028, P16EF80010, P16EM08003, P16EM09002, P16EM09003, P16EM09004, P16EVO130002, P16EVO130003, P16EVO140001, P16EVO140002, P16EVO140003, P16EVO140005, P16EVO140006, P16EVO140007, P16EVO140008  Model Number: 728132, Serial Number(s):  EP16ER100003,EP16ER100004,EP16ER100005,EP16ER100007,EP16ER100008,EP16ER110003, EP16ER110004,EP16ER110005,EP16ER110006,EP16ER110007,EP16ER110008,EP16ER110009, EP16ER110010,EP16ER110011,EP16ER110012,EP16ER110013,EP16ER110014,EP16ER110015, EP16ER110016,EP16ER110017,EP16ER110018,EP16ER110019,EP16ER110020,EP16ER110021, EP16ER110022,EP16ER110023,EP16ER110024,EP16ER120001,EP16ER120002,EP16ER120003, EP16ER120004,EP16ER120005,EP16ER120006,EP16ER120007,EP16ER120008,EP16ER120009, EP16ER120010,EP16ER120011,EP16ER120012,EP16ER120013,EP16ER120015,EP16ER120016, EP16ER120017,EP16ER120018,EP16ER130001,EP16ER130002,EP16ER130003,EP16ER130004, EP16ER130005,EP16ER130006,EP16ER130007,EP16ER130008,EP16ER130009,EP16ER130010, EP16ER130011,EP16ER130012,EP16ER130013,EP16ER130014,EP16ER130015,EP16ER130016, EP16ER130017,EP16ER130018,EP16ER130019,EP16ER130020,EP16ER130021,EP16ER130022, EP16ER130023,EP16ER130024,EP16ER130025,EP16ER130026,EP16ER130027,EP16ER130028, EP16ER130029,EP16ER130030,EP16ER130031,EP16ER130032,EP16ER130033,EP16ER130034
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic Distribution: AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA. Foreign distribution: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Congo, Ecuador, Egypt, France, Germany, Ghana, Greece, Gutamala, Hungray, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Lybyan Arab JHamahiri, Lithuania, Malawi, Mexico, Myanmar, Namibia, Nepal, Netherlands, Oman, Palestine, Paraguay, Philippines, Poland, Portugal, Romania,Russia, Rwanda, Saudi Arabia, Senegal, South Agrica, South ZKorea, Spain, Sri Lanka, Switzerland, Tunisia, Turkey, Uganda, UAE, Venezuela, Vietnam, Zambia.
  • 제품 설명
    MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
  • Manufacturer

Manufacturer

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