Recalls / —

—#27923

Product

Gyroscan ACS-NT with software versions R6x, R7x, R8x

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K932645

Affected lot / code info

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

Why it was recalled

Patient burns from cables near or in contact with the patient during use

Root cause (FDA determination)

Other

Action the firm took

On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern

The firm distributed units to hospitals and medical centers throughout the U.S.

Timeline

Recall initiated

2002-11-21

Posted by FDA

2003-09-12

Terminated

2005-01-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27923. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.