Events

Device Recall BIPLANE XRay Imaging Systems with Velara Generator 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
    56093
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2449-2010
  • 사례 시작날짜
    2010-02-04
  • 사례 출판 날짜
    2010-09-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92624
  • 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
    A lock-up might occur inside the velara generator due to intermittent shorts inside the system. the problem can only resolved by a warm or cold system restart. in exceptional cases the power converters of the kvma unit in the generator are damaged and the system can not be restarted.
  • 조치
    On 02/04/2010, Philips Healthcare began sending out the URGENT-Device Correction Notices to their consignees. The firm issued two notifications, one for the Allura Integris and Xper FD10C, FD10F, FD10F/C and FD20 Monoplane X-Ray imaging systems with the Velara Generator. The second notification is for the Allura Integris Xper FD10 and FD20 Biplane X-ray imaging systems with the Velara Generator. This notice informs the consignees that a system locks up during a critical interventional case and it might impose a serious injury to patients. This lock up issue could only be resolved by a warm or cold system restart. A warm restart would take about 90 seconds or a cold restart would take about four minutes, and the device could not be used during this time. If the system does not work after the restart, the consignees should contact the Philips Healthcare Customer Service Representative at 1-800-772-9377 #5 (then follow prompts). A service representative will visit each consignee and conduct a software and hardware upgrade.

Device

Device Recall BIPLANE XRay Imaging Systems with Velara Generator
  • 모델명 / 제조번호(시리얼번호)
    Each unit is identified with a SITE number:  76992, 103526, 103581, 103921, 104020, 104021, 104068, 104386,  104497, 104628, 104926, 104950, 104953, 104959, 105184, 105399, 105581, 105585, 105654, 504655, 504674, 504733, 504742, 504779, 504868, 504921, 505067, 505068, 505120, 505356, 505380, 505530, 505611, 505703, 505903, 506008, 506026, 506069, 506119, 506509, 506655, 519118, 519136, 519196, 519197, 519678, 519730, 519981, 520275, 520582, 520666, 520688, 520756, 520793, 520949, 520964, 521149, 521325, 521525, 522136, 522456, 530396, 530653, 530654, 530660, 531649, 531758, 531799, 531926, 531939, 532152, 532218, 532240, 532241, 532383, 532614, 533288, 533290, 533397, 534131, 534156, 534786, 535345, 535761, 535775, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537175, 537593, 537631, 537804, 538028, 538095, 538099, 538157, 538172, 538387, 538409, 538514, 538516, 539213, 539326, 539628, 540184, 540237, 540461, 540721, 541237, 541238, 541239, 541276, 541577, 541589, 541590, 542382, 542413, 542557, 542714, 542963, 543289, 543411, 543690, 543879, 543953, 543989, 544306, 544395, 544543, 544635, 544656, 544668, 544844, 545025, 545262, 545396, 545518, 545583, 545604, 545753, 545882, 545884, 545997, 546013, 546119, 546149, 546569, 546906, 547173, 547215, 547431, 547642, 547715, 547769, 547823, 547922, 548005, 548020, 548036, 548082, 548140, 548288, 548383, 548618, 549202, 549242, 549368, 549370, 549903, 550198, 550691, 550758, 550812, 550935, 551855, 552355, 552599, 552639, 552969, 553685, 553699, 553766, 554763, 554802, 554970, 555293, 555299, 555356, 555834, 558604, 558945,  41443586, 41443609, 41443627, 41443647, 41443727, 41443765, 41443804, 41443909, 41444645, 41444647, 41444650, 41444689, 41444752, 41444816, 41445118, 41445432, 41445448, 41445501, 41445538, 41445615, 41445628, 41446230, 41446262, 41446773, 41455885, 41455897, 41455920, 41455925, 41455933, 41455944, 41455953, 41660520, 41780160, 41793290, 41795344, 41796154, 42046093, 42046440, 42057324, 42064058, 42067824, 42394072, 42479274, 42508759, 42553772, 42564341, 42625859, 42735090, 42891020, 42891095, 42891704, 43043666, 43058934, 43164789, 43173591, 43315510, 43436747, 43443622, 43453735, 43635004, 43670742, 43848923, 44028554, 44066424, 44584972, 44616211, 44654768, 44735751, and 44892370.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. || The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. || The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".
  • 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