Events

Device Recall Philips Easy Diagnost Eleva Conventional R/F system 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
    52100
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0479-2011
  • 사례 시작날짜
    2009-01-21
  • 사례 출판 날짜
    2010-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82093
  • 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, stationary - Product Code KPR
  • 원인
    Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. there is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.
  • 조치
    Philips Medical Systems issued URGENT-Device Correction letters dated January 27, 2009 to consignees describing the issue with the Easy Diagnost Eleva GXR RF systems. The consignees were informed of the potential for incorrect diagnosis or treatment if an incorrect image is used for diagnosis. Consignees should contact the Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FC0 70600030" with any communication.

Device

Device Recall Philips Easy Diagnost Eleva Conventional R/F system
  • 모델명 / 제조번호(시리얼번호)
    Site Numbers:  506250, 506251, 506276, 519152, 520209, 521153, 530573, 530607, 532426, 532779, 533491, 533574, 534207, 534419, 534644, 534647, 534675, 534803, 534945, 535378, 535437, 535785, 536051, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536933, 536941, 536973, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538814, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539377, 539378, 539379, 539411, 539419, 539488, 539501, 539519, 539527, 539529, 539530, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884, 542061, 542121, 542122, 542205, 542308, 542401, 542521, 542537, 542589, 542593, 542716, 542829, 542849, 543136, 543144, 543224, 543241, 543249, 543275, 543297, 543331, 543369, 543415, 543426, 543619, 543620, 543660, 543723, 543754, 543755, 543771, 543776, 543803, 543841, 544075, 544113, 544172, 544228, 544236, 544297, 544341, 544417, 544480, 544481, 544568, 544648, 544654, 544695, 544937, 544999, 545000, 545038, 545120, 545163, 545166, 545213, 545231, 545234, 545244, 545391, 545452, 545710, 545746, 545780, 545783, 545824, 545844, 545923, 545948, 545951, 546029, 546155, 546490, 546524, 546551, 546583, 546602, 547054, 547189, 547243, 547297, 547304, 547371, 547598, 547599, 547655, 547657, 547744, 547758, 547759, 547798, 547936, 547937, 548021, 548276, 548290, 548302, 548382, 548559, 548784, 549008, 549080, 549269, 549270, 549381, 549416, 549509, 549557, 549616, 549663, 550072, 550079, 550197, 550313, 550591, 550804, 550936, 550960, 551005, 551416, 551573, 551616, 551645, 551721, 551759, 551941, 551954, 551980, 552204, 552205, 552211, 552324, 552363, 552364, 552407, 552502, 552579, 552594, 552626, 552640, 552917, 552918, 552965, 552966, 553013, 553172, 553207, 553224, 553230, 553275, 553349, 553387, 553441, 553448, 553455, 553563, 553850, 553893, 553900, 553926, 554061, 554483, 554581, 554641, 554721, 554722, 554769, 555052, 555269, 555458, 555524, 555574, 555626, 555964, 555993, 556124, 556621, 556622, 556726, 556785, 556984, 557177, 557259, 557272, 558437, 558596, 558734, 558775, 41443799, 41444441, 41658234, 41862667, 42039161, and 537967 / 49371595.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationside Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, and WV. Devices are not distributed to any foreign consignees.
  • 제품 설명
    Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.
  • 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