Events

AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Co. Phillips 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
    33873
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0207-06
  • 사례 시작날짜
    2005-10-12
  • 사례 출판 날짜
    2005-11-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42642
  • 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, Angiographic - Product Code IZI
  • 원인
    Potential for high voltage exposure involving the injector interface connector of patient support tables.
  • 조치
    On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

Device

AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
  • 모델명 / 제조번호(시리얼번호)
    Site numbers: 530664, 519535, 532292, 533551, 538806, 532150, 504797, 504807, 504730, 533418, 536796, 534743, 532178, 520525, 504798, 504806, 534681, 534731, 536899, 522418, 536641, 533897, 534221, 505651, 530391, 530390, 532074, 535931, 536646, 539094, 522162, 536007, 535979, 536138, 504659, 536136, 540048, 539628, 519533, 535946, 533796, 538234, 504666, 531830, 505861, 505860, 540237, 506564, 536592, 532532, 536067, 505587, 535274, 532227, 535278, 520309, 537386, 537630, 506148, 530666, 521320, 521892, 530667, 533763, 530392, 533762, 538902, 531837, 531834, 520814, 537357, 521548, 534218, 521589, 105784, 536433, 536234, 530669, 532244, 520524, 521463, 535367, 521890, 520755, 520523, 532245, 535285, 534678, 536717, 532264, 534217, 506621, 530370, 538369, 534682, 530368, 534215, 530460, 505805, 534810, 535951, 538406, 538744, 538476, 538903, 537065, 534477, 534479, 536163, 534478, 536014, 104925, 534476, 532294, 522253, 520236, 519812, 504750, 536154, 536155, 530715, 535728, 534639, 535727, 534638, 538482, 538512, 506049, 536777, 104149, 531948, 519594, 519771, 531760, 535793, 533283, 519677, 533284, 538514, 506658, 533278, 533282, 506657, 533287, 533286, 533285, 534232, 506654, 522245, 506047, 506170, 532533, 532614, 520809, 532616, 506178, 532535, 535813, 532534, 532617, 532613, 534856, 532615, 532246, 521763, 539204, 522138, 520632, 535342, 531806, 504747, 531805, 521545, 521537, 533738, 532799, 532215, 522038, 521315, 520630, 104954, 535566, 104958, 531961, 538102, 538538, 103711, 535439, 104952, 537020, 534798, 521314, 520631, 104956, 104957, 104955, 522440, 506322, 105656, 105655, 537985, 104075, 531944, 521312, 534796, 535424, 540421, 105670, 522135, 531943, 521311, 505759, 104514, 104515, 521675, 104670, 531945, 535376, 536901, 521802, 520251, 506616, 506403, 531942, 530584, 531957, 531817, 531813, 506785, 538464, 521318, 522293, 504940, 538516, 534876, 521512, 532446, 531946, 505925, 533343, 520491, 534246, 531949, 532445, 505968, 536178, 538269, 535667, 531951, 536715, 536090, 535702, 534452, 534255, 505707, 522247, 522243, 520481, 522250, 505679, 531931, 506476, 505106, 505668, 532249, 536789, 505107, 537804, 535927, 531753, 535615, 534813, 531752, 538485, 538486, 538228, 521650, 520977, 538466, 534233, 105674, 537024, 521711, 534724, 533967, 105940, 505486, 104642, 539220, 105390, 519901, 521820, 519213, 538028, 533476, 534420, 534158, 520783, 530421, 531728, 537698, 520793, 104890, 532080, 533966, 536028, 533955, 536034, 536031, 536042, 532077, 536035, 533956, 536037, 534730, 533401, 105960, 538771, 534150, 519738, 534787, 534630, 520681, 500038, 534152, 506637, 535418, 520431, 520004, 504665, 520660, 519214, 521659, 535779, 105947, 535415, 535396, 519541, 521854, 520761, 536171, 103128, 506370, 105912, 519548, 534431, 538368, 520680, 534569, 506230, 105615, 506232, 536174, 519576, 536798, 534160, 536379, 534237, 519211, 520430, 540841, 539479, 539107, 506717, 538465, 536993, 537784, 535814, 505572, 521853, 500028, 500029, 522065, 520948, 520882, 506169, 519115, 532652, 522177, 532649, 537205, 505719, 504789, 534716, 504493, 504792, 532990, 535614, 534717, 506408, 519733, 534758, 534440, 519680, 534811, 540622, 522191, 534374, 535224, 522397, 506397, 519899, 538386, 519894, 105136, 533395, 505254, 505989, 540082, 500042, 519195, 105081, 105082, 105186, 533236, 537266, 519198, 535492, 520779, 533772, 532611, 533922, 537073, 531651, 532986, 532612, 522119, 532263, 535400, 522118, 105140, 105191, 505809, 533085, 533084, 103562, 537118, 506538, 105598, 102948, 103265, 534427, 531808, 103561, 531762, 540288, 537934, 538193, 538157, 506540, 506539, 532262, 520956, 103331, 530485, 505876, 103564, 539099, 104464, 533619, 103780, 102499, 540016, 537805, 102560, 538813, 105779, 521661, 533861, 103781, 535635, 522458, 535611, 533543, 519537, 532225, 519534, 504770, 537597, 538479, 534250, 539322, 521770, 521769, 105157, 505281, 521222, 535173, 534545, 534380, 538194, 535202, 537644, 534565, 533857, 536471, 535250, 536639, 534270, 534268, 536173, 537466, 534108, 521154, 534874.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were distributed nationwide to hospitals/medical centers.
  • 제품 설명
    AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • 제조사 주소
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA