Z-2270-2014 Class II Terminated
FDA device recall Z-2270-2014 was initiated by Invivo Corporation on June 30, 2014 and is designated Class II. Reason for recall: The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system. The recall status is terminated (terminated December 14, 2016). Affected quantity: 573 devices..
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- June 30, 2014
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 573 devices.
Product Description
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.
Reason for Recall
The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
Distribution Pattern
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.
Code Information
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