NRAC Issue #1637 ADDENDUM July 3, 2007 PRODUCT a) Gyroscan MRI RECALL NUMBER # Z-0981-2007 PRODUCT b) Intera MRI RECALL NUMBER # Z-0982-2007 PRODUCT c) Achieva MRI RECALL NUMBER # Z-0983-2007 PRODUCT d) Panorama 1.0T MRI RECALL NUMBER # Z-0984-2007 CODE a) Site numbers: 6662, 6841, 6947, 10367, 10409, 13020, 13056, 13334, 13338, 13408, 13413, 13532, 13538, 13606, 13730, 13748, 13753, 13754, 13864, 13894, 13932, 13947, 13948, 13965, 3966, 13967, 13976, 13977, 14065, 14117, 14128, 14134, 14144, 16745, 17280, 17336, 17394, 17410, 17421, 17459, 17481, 17482, 17483, 17533, 17544, 17585, 17648, 17664, 17683, 17688, 25958, 25966, 25969, 25986, 26011, 26074, 26119, 26133, 26135, 26149, 26150, 26178, 26201, 26219, 26224, 26269, 34694, 35172, 35362, 35394, 35452, 35491, 37911, 37938, 37941, 37979, 37986, 37996, 37997, 38111, 38143, 38189, 38257, 38303, 38304, 38345, 38415, 38420, 38438, 38441, 38650, 38651, 38652, 38661, 38749, 38797, 38865, 38893, 38966, 38984, 40314, 40903, 40904, 40975, 41064, 41147, 41250, 41333, 41342, 41345, 41346, 41362, 41392, 41440, 41459, 44268, 44793, 44813, 44832, 44876, 44891, 44892, 44952, 44994, 45006, 45009, 45016, 45036, 45037, 45046, 45063, 45065, 45071, 46628, 46846, 47043, 47058, 50009, 50042, 50226, 50309, 50336, 50378, 50390, 50402, 50407, 50411, 50412, 50426, 50430, 50432, 59236, 59252, 59357, 59384, 59427, 59428, 59435, 59475, 59483, 59488, 59556, 59637, 59648, 59707, 59712, 62450, 62457, 62658, 62659, 62801, 62953, 67523, 68196, 73894, 73920, 73974, 76320, 76321, 76341, 76352, 76358, 76402, 76475, 76477, 76480, 76807, 76847, 76848, 78104, 82506, 82546, 82547, 82580, 82582, 82583, 82610, 82627, 82668, 82837, 83044, 83071, 83615, 83708, 83876, 85156, 91351, 91649, 100444, 100463, 101131, 101581, 101930, 102440, 104349, 104455, 105607, 250030, 250082, 250210, 250320, 250451, 250473, 250502, 504244, 504250, 504741, 504897, 521535, 531705, 531862, 532988, 533079, 533741, 534571, 534942, 534943, 536929, 536979, 537591, 538075, 540134, 541042, 542669, 543170, 543400, 543845, 544503, 545176, X0003, X0034, X0054, X0067, X0161, X0162, X0164, X0165, X0214, X0592, X0599, X0608, X0707, X0708, X0716, X0717, X0885, X0940, X0942, X1019, X1042, X1080, X1081, X1083, X1084, X1085, X1086, X1179, X1188, X1231, X1270, X1271, X1272, X1348, X1352, X1353, X1373, X1577 b) Site numbers: 10009, 10353, 10432, 13057, 13058, 38134, 38317, 41391, 41441, 62832, 63046, 76919, 82507, 82534, 82678, 83051, 83080, 83301, 83303, 83306, 83325, 83395, 83396, 83616, 83631, 83802, 83804, 83916, 83940, 83941, 83946, 83995, 84418, 84433, 84477, 84478, 84484, 84700, 84820, 84860, 84861, 84887, 84899, 85023, 85119, 85139, 85141, 85157, 85158, 85172, 85433, 85436, 85442, 85443, 85500, 85684, 85685, 85686, 85688, 86012, 86019, 86020, 86056, 86080, 86082, 86083, 86085, 86121, 86147, 86148, 86184, 86236, 86248, 86250, 86280, 86281, 86287, 86292, 86293, 86313, 86316, 86317, 86334, 86335, 86368, 86379, 86380, 86381, 86404, 86406, 86407, 86408, 86409, 86410, 86413, 86555, 86556, 86557, 86558, 86559, 86560, 86570, 86595, 86596, 86597, 86925, 86968, 87010, 87011, 87018, 87019, 87033, 87034, 87036, 87038, 87053, 87062, 87067, 87135, 87145, 87146, 87147, 87148, 87161, 87168, 87183, 87188, 87309, 87310, 87311, 87355, 87526, 87527, 87604, 87605, 87607, 100214, 100323, 100449, 100459, 100460, 100461, 100462, 100469, 100478, 100629, 100679, 100745, 100785, 100786, 100826, 100832, 100886, 100916, 101056, 101070, 101084, 101111, 101138, 101162, 101165, 101206, 101313, 101347, 101408, 101412, 101416, 101420, 101423, 101425, 101429, 101431, 101432, 101477, 101551, 101560, 101561, 101572, 101584, 101585, 101595, 101608, 101780, 101874, 101877, 101878, 101934, 101946, 101953, 101976, 102003, 102004, 102018, 102095, 102101, 102110, 102137, 102157, 102194, 102353, 102492, 102497, 102524, 102547, 102548, 102561, 102569, 102571, 102614, 102617, 102671, 102698, 102699, 102709, 102718, 102724, 102786, 102827, 102889, 102907, 102933, 102975, 102978, 102980, 103041, 103062, 103064, 103065, 103068, 103098, 103099, 103101, 103126, 103135, 103136, 103142, 103143, 103149, 103151, 103166, 103171, 103207, 103215, 103243, 103247, 103249, 103258, 103286, 103291, 103324, 103333, 103347, 103351, 103373, 103416, 103417, 103450, 103509, 103530, 103540, 103544, 103547, 103552, 103579, 103580, 103582, 103592, 103611, 103620, 103631, 103647, 103665, 103688, 103697, 103703, 103704, 103770, 103779, 103782, 103808, 103811, 103817, 103818, 103847, 103904, 103907, 103909, 103911, 103946, 104019, 104022, 104027, 104032, 104054, 104069, 104070, 104079, 104082, 104095, 104102, 104124, 104134, 104138, 104144, 104193, 104336, 104340, 104343, 104378, 104392, 104393, 104446, 104467, 104531, 104532, 104635, 104639, 104765, 104800, 104808, 104871, 104880, 104886, 104887, 104897, 104900, 104901, 104912, 104918, 104919, 104928, 104942, 105148, 105252, 105271, 105290, 105303, 105311, 105313, 105314, 105315, 105317, 105348, 105358, 105368, 105373, 105424, 105471, 105486, 105487, 105488, 105509, 105657, 105664, 105679, 105687, 105695, 105720, 105741, 105925, 105926, 105929, 105938, 225313, 250033, 250050, 250122, 250156, 250180, 250229, 250293, 250498, 250890, 500007, 500009, 500010, 500034, 500051, 504243, 504249, 504298, 504335, 504342, 504346, 504349, 504350, 504351, 504353, 504400, 504403, 504409, 504412, 504527, 504531, 504543, 504608, 504628, 504653, 504662, 504670, 504738, 504793, 504866, 504899, 504927, 504952, 504954, 504974, 504979, 505007, 505021, 505049, 505050, 505275, 505337, 505399, 505400, 505490, 505514, 505568, 505678, 505682, 505688, 505689, 505777, 505785, 505815, 505914, 505940, 505941, 505943, 506034, 506044, 506120, 506183, 506188, 506190, 506203, 506219, 506296, 506324, 506385, 506570, 506670, 506691, 506777, 506784, 519129, 519133, 519147, 519525, 519545, 519569, 519765, 519890, 520002, 520113, 520176, 520190, 520354, 520355, 520579, 520662, 520679, 520700, 520708, 520709, 520754, 520765, 521228, 521415, 521429, 521432, 521524, 521678, 521751, 521908, 521911, 521927, 521939, 522297, 522419, 522421, 522441, 530363, 530364, 530366, 530651, 531652, 531712, 531766, 531767, 531925, 531934, 532282, 532463, 532705, 532709, 532710, 532711, 533489, 533682, 533953, 534643, 534676, 534684, 534686, 534695, 534765, 534777, 535327, 535328, 535329, 535330, 535486, 535505, 536126, 536262, 536318, 536482, 536589, 536885, 537391, 537690, 537980, 538077, 538253, 538429, 538800, 538841, 539236, 539276, 539280, 539281, 539531, 539585, 539597, 539644, 539882, 540285, 540412, 540454, 540793, 540794, 540945, 541125, 541441, 541442, 541575, 541740, 541819, 541827, 541973, 542116, 542270, 542275, 542580, 543118, 543119, 543280, 543293, 543724, 543824, 543892, 543966, 543976, 544085, 544112, 544116, 545008, 545084, 545255, 545541, 545573, 545832, 545842, 545940, 545952, 545965, 545980, 546177, 546970, 547066, 547075, 547235, 547261, 547587, 547903, 547934, 547953, 547979, 547985, 548050, 548065, 548320, 549239, 549243, 549429, 549592, 549858, 550035, 550057, 550060, 550085, 550256, 550391, 550422, 550909, 551037, 551689, 552498, 552508, X1215, X1216, X1281, X1412, X1523, X1562, X1593, X1594, X1595, X1602, X1648, X1649, X1662, X1664, X1668, X1669, X1670, X1693, X1730, X1739, X1740, X1741, X1742, X1743, X1744, X1753, X1756, X1759 c) Site numbers: 102114, 103789, 104087, 104163, 104658, 104879, 104924, 105291, 105475, 105624, 500036, 500045, 504634, 505045, 505046, 505048, 505357, 505705, 505879, 506389, 506390, 506798, 506842, 519120, 519124, 519127, 519216, 519522, 519552, 519892, 519933, 520007, 520191, 520315, 520429, 520432, 520667, 520690, 520966, 521002, 521097, 521130, 521134, 521150, 521152, 521159, 521465, 521466, 521509, 521513, 521518, 521526, 521529, 521536, 521542, 521689, 521718, 521737, 521772, 521804, 521902, 521929, 521932, 521934, 522010, 522264, 522368, 522422, 528928, 530362, 530395, 530422, 530423, 530426, 530427, 530680, 530771, 530774, 530776, 530790, 531765, 531786, 532068, 532410, 532417, 532418, 532470, 532491, 532537, 532643, 532809, 532840, 532851, 532980, 532981, 533063, 533076, 533082, 533086, 533116, 533320, 533393, 533403, 533588, 533743, 533744, 533746, 533747, 533759, 533859, 534069, 534165, 534301, 534344, 534503, 534561, 534587, 534636, 534671, 534693, 534700, 534715, 534721, 534732, 534778, 534838, 534841, 534845, 534925, 534929, 534935, 534944, 534961, 535001, 535189, 535208, 535211, 535222, 535247, 535288, 535289, 535290, 535331, 535353, 535392, 535394, 535404, 535487, 535839, 536597, 536649, 536651, 536652, 536675, 536679, 536804, 536943, 537033, 537063, 537133, 537176, 537461, 537508, 537729, 537736, 537795, 537832, 537871, 537880, 538007, 538300, 538452, 538463, 538491, 538525, 538526, 538779, 538789, 538941, 539180, 539183, 539216, 539271, 539327, 539420, 539477, 539550, 539583, 539591, 539703, 539938, 539945, 540015, 540243, 540444, 540469, 540490, 540707, 540999, 541084, 541147, 541200, 541267, 541404, 541491, 541613, 541637, 541797, 541876, 541888, 542595, 542970, 543247, 543278, 543286, 543321, 543696, 543697, 543699, 543888, 543917, 543944, 543992, 544006, 544027, 544563, 544565, 544585, 544640, 544659, 544667, 544704, 544736, 544792, 544911, 545018, 545154, 545219, 545236, 545291, 545294, 545711, 545879, 545914, 545932, 545943, 545999, 546004, 546010, 546015, 546019, 546055, 546096, 546104, 546553, 546570, 546600, 546610, 546637, 546649, 546669, 546730, 546774, 546848, 546864, 546941, 547018, 547023, 547160, 547162, 547228, 547310, 547389, 547585, 547639, 547640, 547698, 547724, 547785, 547788, 547792, 547899, 547941, 547957, 548008, 548010, 548012, 548037, 548359, 548634, 548689, 548729, 548745, 548758, 548760, 548792, 548918, 549009, 549024, 549371, 549373, 549412, 549541, 549666, 549819, 549923, 549936, 550040, 550044, 550195, 550208, 550276, 550279, 550344, 550364, 550366, 550373, 550410, 550731, 550831, 550876, 550926, 550972, 551271, 551401, 551403, 551587, 551656, 551658, 551674, 551872, 551873, 551874, 551875, 551876, 551877, 551878, 551879, 551880, 552183, 552189, 552516, 552539, 552588, 552591, 552602, 552604, 552622, 552645, 552805 d) Site #'s: 521810, 533745, 533860, 533900, 534276, 534278, 535230, 535273, 535664, 536972, 537852, 538574, 538616, 539265, 539374, 539514, 540482, 541065, 541851, 542236, 542244, 543822, 544039, 544148, 544696, 544723, 545034, 545143, 545732, 545902, 545918, 545981, 546206, 546594, 546654, 546722, 546728, 547843, 547897, 548040, 548041, 548064, 549389, 549909, 550324, 550358, 550398, 550439, 550449, 550621, 551025, 551583, 552453, 552526, 552609 MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands RECALLED BY Philips Medical Systems North America Co. Phillips, Bothell, WA QUANTITY 287 Gyroscan, 640 Intera, 350 Achieva, 55 Panorama 1.0T DISTRIBUTION Nationwide REASON Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site. ---------------------------------------------------------------------------