Events

Philips Expression Information Portal (IP5) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invivo Corporation 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
    74296
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2867-2016
  • 사례 시작날짜
    2014-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147097
  • 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
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • 원인
    Frozen display numerics and disabled menu keys after extended run time. this customer notification was sent august 22, 2014.
  • 조치
    A recall notification letter was sent to hospitals who purchased the recalled product via UPS March 2014. The letter instructed users to power cycle the IP5 unit every day. This is done by pressing the power button on the side of the unit. Customers were instructed to communicate the recall to all those subject and to attach an addendum to the IP5 Instructions for Use. The firm advised customers to call their Philips representative, option 1, then option 2, if they had any questions or concerns.

Device

Philips Expression Information Portal (IP5)
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, 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US23200292, US23200293, US23200294, US23200295, US23200296, US23200297, US23200298, US23200299, US23200300, US23200301, US23200302, US23200303, US23200304, US23200305, US23200306, US23200307, US23200308, US23200309, US23200310, US23200311, US23200312, US23200313, US23200314, US23200315, US23200316, US23200317, US23200318, US23200319, US23200320, US23200321, US23200322, US23200323, US23200324, US23200325, US23200326, US23200327, US23200328, US23200329, US23200330, US23200331, US23200332, US23200333, US23200334, US23200335, US23200336, US23200337, US23200338, US23200339, US23200340, US23200341, US23200342, US23200343, US23200344, US23200345, US23200346, US23200347, US23200349, US23200350, US23200351, US23200352, US23200353, US23200354, US23200356, US23200357, US23200358, US23200359, US23200360, US23200361, US23200362, US23200363, US23200364, US23200365, US23200366, US23200367, US23200368, US23200369, US23200370, US23200371, US23200372, US23200373, US23200374, US23200375, US23200376, US23200377, US23200378, US23200379, US23200380, US23200381, US23200382, US23200383, US23200385, US23200386, US23200387, US23200388, US23200389, US23200390, US23200391, US23200393, US23200394, US23200395, US23200397, US23200398, US23200399, US23200400, US23200401, US23200402, US23200403, US23200405, US23200406, US23200407, US23200408, US23200410, US23200413, US23200415, US23200416, US23200419, US23200421, US23200422, US23200423, US23200424, US23200425, US23200427, US23200428, US23200429, US23200431, US23200434, US34600510, US34600511, US34600512, US34600513, US34600514, US34600515, US34600516, US34600517, US34600518, US34600519, US34600520, US34600521, US34600522, US34600523, US34600524, US34600525, US34600526, US34600528, US34600529, US34600530, US34600531, US34600532, US34600533, US34600534, US34600535, US34600536, US34600537, US34600538, US34600539, US34600540, US34600541, US34600542, US34600543, US34600544, US34600545, US34600546, US34600547, US34600548, US34600549, US34600550, US34600551, US34600552, US34600553, US34600554, US34600555, US34600556, US34600557, US34600558, US34600559, US34600560, US34600561, US34600562, US34600563, US34600564, US34600565, US34600566, US34600567, US34600568, US34600569, US34600570, US34600571, US34600572, US34600573, US34600574, US34600575, US34600576, US34600577, US34600578, US34600579, US34600580, US34600581, US34600582, US34600583, US34600584, US34600585, US34600586, US34600587, US34600588, US34600589, US34600590, US34600591, US34600592, US34600592, US34600593, US34600594, US34600595, US34600596, US34600597, US34600598, US34600599, US34600600, US34600601, US34600602, US34600603, US34600604, US34600605, US34600606, US34600607, US34600608, US34600609, US34600610, US34600611, US34600612, US34600613, US34600614, US34600615, US34600616, US34600617, US34600618, US34600619, US34600620, US34600621, US34600622, US34600623, US34600624, US34600625, US34600626, US34600627, US34600628, US34600629, US34600630, US34600631, US34600632, US34600633, US34600634, US34600635, US34600636, US34600637, US34600638, US34600639, US34600640, US34600641, US34600642, US34600643, US34600644, US34600645, US34600646, US34600647, US34600648, US34600649, US34600650, US34600651, US34600652, US34600653, US34600654, US34600655, US34600656, US34600657, US34600658, US34600659, US34600660, US34600661, US34600662, US34600663, US34600664, US34600665, US34600666, US34600667, US34600668, US34600669, US34600670, US34600671, US34600672, US34600673, US34600674, US34600675, US34600676, US34600677, US34600678, US34600679, US34600680, US34600681, US34600682, US34600683, US34600684, US34600685, US34600686, US34600687, US34600688, US34600689, US34600690, US34600691, US34600692, US34600693, US34600694, US34600695, US34600696, US34600697, US34600698, US34600699, US34600700, US34600701, US34600702, US34600703, US34600704, US34600705, US34600706, US34600707, US34600708, US34600709, US34600710, US34600711, US34600712, US34600713, US34600714, US34600715, US34600716, US34600717, US34600718, US34600719, US34600720, US34600721, US34600722, US34600723, US34600724, US34600729, US34600730, US34600731, US34600732, US34600733, US34600734, US34600735, US34600736, US34600737, US34600738, US34600739, US34600740, US34600741, US34600742, US34600743, US34600744, US34600745, US34600746, US34600747, US34600748, US34600749, US34600750, US34600751, US34600752, US34600753, US34600754, US34600755, US34600756, US34600757, US34600758, US34600759, US34600760, US34600761, US34600762, US34600763, US34600764, US34600765, US34600766, US34600767, US34600768, US34600769, US34600770, US34600771, US34600772, US34600773, US34600774, US34600775, US34600776, US34600777, US34600778, US34600779, US34600780, US34600781, US34600782, US34600783, US34600784, US34600785, US34600786, US34600787, US34600788, US34600789, US34600790, US34600791, US34600792, US34600793, US34600794, US34600795, US34600796, US34600797, US34600798, US34600799, US34600800, US34600801, US34600802, US34600803, US34600804, US34600805, US41600814, US41600815, US41600816, US41600817, US41600818, US41600819, US41600820, US41600821, US41600822, US41600823, US41600824, US41600825, US41600826, US41600827, US41600828, US41600829, US41600830, US41600831, US41600832, US41600833, US41600834, US41600835, US41600836, US41600837, US41600838, US41600839, US41600840, US41600841, US41600842, US41600843, US41600844, US41600845, US41600846, US41600847, US41600848, US41600849, US41600850, US41600851, US41600852, US41600853, US41600854, US41600855, US41600856, US41600857, US41600858, US41600859, US41600860, US41600861, US41600862, US41600863, US41600865, US41600866, US41600867, US41600868, US41600869, US41600870, and US41600871.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England
  • 제품 설명
    Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • 제조사 주소
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA