Gyroscan ACS-NT with software versions R6x, R7x, R8x
- Company
- Philips Medical Systems
- Recall Initiated
- November 21, 2002
- Posted
- September 12, 2003
- Terminated
- January 13, 2005
- Recall Number
- Z-1227-03
- Quantity
- 435 total devices
- Firm Location
- Bothell, WA
Reason for Recall
Patient burns from cables near or in contact with the patient during use
Distribution
The firm distributed units to hospitals and medical centers throughout the U.S.
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
Root Cause
Other
Action Taken
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.