Events

Device Recall Philips Expression IP5 Information Portal 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
    68956
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2270-2014
  • 사례 시작날짜
    2014-06-30
  • 사례 출판 날짜
    2014-08-19
  • 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=129112
  • 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
    The wireless function of the ip5 radio could be interrupted causing loss of wireless communication between the ip5 and host monitoring system.
  • 조치
    The firm, Philips Healthcare, sent an "URGENT - Field Safety Notice" dated June 30, 2014 to its customers. The notice describes the product, problem and actions to be taken. The notice also provides the customers with instructions for use while waiting for the update to the IP5. A Philips representative will contact you regarding your affected device. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.

Device

Device Recall Philips Expression IP5 Information Portal
  • 모델명 / 제조번호(시리얼번호)
    Product: 865471 Number 453564251511 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, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200257, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, 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, US23200409, US23200410, US23200411, 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, 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, US34600786, US34600787, US34600788, US34600789, US34600790, US34600791, US34600792, US34600794, US34600795, and US34600796
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Philips IP5 Information Portal || The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • 제조사 주소
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA