Company: Philips Medical Systems
Date of Enforcement Report: 9/24/03
Class: II
PRODUCT
a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03;
b) Gyroscan NT-Intera. Recall # Z-1228-03;
c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03.
REASON
Patient burns from cables near or in contact with the patient during use.
CODE
a) 6808, 87145, 86595, 50426, 100214, 101131, 63045, 103171, 41391, 38189, 37996, 85119, 84433, 83876, 102571, 86121, X1577, 44876, 86368, 44793, 87011, 101572, 100916, 82507, 85500, 13606, 86147, 76475, 86235, X1663, 38380, 101111, 37929, X1412, 86280, 37941, 38134, 101608, 25924, 84418, 101138, 6947, 86292, 83044, 63046, 86293, 86406, 102095, 50309, 87355, X1348, 101976, 76919, 17533, 37911, X0038, 26178, 85443, 101946, 13056, 41377, 76320, 59428, 84861, 14134, 76480, 101780, 50430, 50430, 50378, 13275, 85139, 45016, 87183, 86559, 102614, 102616, X1374, 101206, 83041, X1664, X1373, X1730, X1084, X1085, X1270, X1582, X1670, X1352, X1083, X1231, X1272, X1669, X1563, X1741, X0165, X1743, X1280, X1086, X0717, X1271, X0942, X0940, X1740, X1081, 86184, 83303, 101056, 103142, 83631, 38415, 59528, 59357, 83616, 101346, 102018, 76477, 38652, 101313, 38508, 50226, 76848, X1759, 86555, 86082, 14117, 86925, 86020, 13894, 103126, 83080, 101874, 17648, 82506, 86410, 86570, 82610, 38731, 17573, 87365, 62659, 82668, 102889, 41346, 87038, 84887, 103207, 86556, X1043, 87311, 52408, X1593, X1753, 83071, 101423, 100679, 38797, 6841, 47029, 13967, 86248, 13754, 101347, 50390, 102548, 87019, 44994, 87605, 101934, 83325, 41392, 86596, 101425, X1594, 82583, X1353, 83306, 25958, 86335, 86317, 76352, 40904, 10009, 85172, 83395, 103258, 45036, 86597, 37938, 100459, 41441, 13748, 38749, 14128, X1756, 101551, 13058, 87135, X1080, 102110, 38143, 37986, 83946, 82955, 100462, 85436, X0034, 62658, 76807, 76469, 25966, 13932, 102724, 87527, 86408, 101188, 38111, 44833, 41362, 41345, 38966, 26219, 26074, 82627, 86411, 85688, 85686, 82626, 87604, 50336, 86019, 87309, 13020, 84860, 38984, X1668, X1602, 13334, 13338, 13948, 102004, 76847, 102003, 6840, 87188, 26149, 13947, 80335, 83802, 10367, 10409, 38345, 85684, 50412, 50411, 100463, 86409, 83804, 38257, 86056, 87033, 45071, X1163, 101162, 102194, 87161, 87146, 84899, 59707, 13413, 85141, 10432, 13977, 58023, 103064, 87018, 86558, 86236, X1693, 102137, 86148, 103143, 84820, 38441, 87062, X0054, 102718, 26150, 103116, 100460, X1757, 82580, 100469, 38661, 86334, 101429, 76321, 101584, 103351, 41250, 85157, 44813, 86560, 82678, 85685, 14065, X1281, 82547, X1595, 41459, 85442, X1662, 41440, X1710, 38650, 101431, 86281, 101432, 83940, 86381, X0084, X1739, 47189, 87053, 38438, 86413, 100323, 10396, 76359, 76358, 17481, 17585, 17483, 17482, 82534, 100461, 86968, 83396, 10353, 86250, 86918, 100478, 83615, 101560, 41064, 13729, 101084, 47043, 17394, 13976, 14144, 84700, 87607, X1216, X1215, 13730, 13864, 100826, 50407, X1648, 17683, 13057, 13966, 87147, 82546, 38651, 86407, 59427, 84478, 84484, 87148, 59384, 59475, 103135, 62953, 86313, 59338, 83394, 59712, 86151, 86083, 62832, 83708, 87310, 26133, 82619, 87168, 87526, 87067, 83051, 101348, X1635, 103041, 102671, 102561, 83916, 38317, 103101, X0162, 84477, 26119, 100785, X1179, X1523, 86080, 85433, 38303, 38304, 86316, 44810, 40975, 83941, 45063, 50432, 101412, 87036, 102907, 45006, 102157, 101165, 101878, 85158, 47058, 41342, 13965, 73974, 86379, 41147, 84859, 102617, 101408, 83995, 83301, 38420, X1649, 86404;
b) Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x, R8x;
c) Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x, R8x.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by Field Change Orders on November 21, 2002. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
435.
DISTRIBUTION
Nationwide.