Events

Rappel de Device Recall Philips Expression IP5 Information Portal

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Invivo Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68956
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2270-2014
  • Date de mise en oeuvre de l'événement
    2014-06-30
  • Date de publication de l'événement
    2014-08-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129112
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Cause
    The wireless function of the ip5 radio could be interrupted causing loss of wireless communication between the ip5 and host monitoring system.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA