Retiro De Equipo (Recall) de Device Recall Philips Expression IP5 Information Portal

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Invivo Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Causa
    The wireless function of the ip5 radio could be interrupted causing loss of wireless communication between the ip5 and host monitoring system.
  • Acción
    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.


  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    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.
  • Descripción del producto
    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


  • Dirección del fabricante
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • Empresa matriz del fabricante (2017)
  • Source