| Class 2 Device Recall OEC 7700 Mobile Fluoroscopy System | |
Date Initiated by Firm | September 28, 2007 |
Date Posted | March 15, 2008 |
Recall Status1 |
Terminated 3 on November 01, 2011 |
Recall Number | Z-0717-2008 |
Recall Event ID |
46349 |
510(K)Number | K000221 |
Product Classification |
Mobile FluoroscopyX-Ray System - Product Code JAA
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Product | GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah |
Code Information |
All Serial Numbers beginning with 79-, which is followed by 2006, 2008, 2009, 2011, 2013, 2014, 2015, 2016, 2018, C0513-C, C0878, C0986, C1016, C1017, C1021, C1037, C1038, C1043, C1044, C1052, C1053, C1054, C1055, C1056, C1060, C1061, C1062, C1063, C1065, C1068, C1069, C1070, C1080, C1082, C1083, C1087, C1088, C1091, C1155, C1162, C1165, C1170, C1176, C1180, C1181, C1184, C1187, C1188, C1189, C1190-M, C1192, C1193, C1195, C1196, C1197, C1198, C1199, C1201, C1203, C1204, C1207, C1208, C1209, C1210, C1212, C1213, C1214, C1216, C1219, C1236, C1238, C1241, C1246, C1248, C1249, C1254, C1255, C1259, C1260, C1263, C1265, C1266, C1269, C1271, C1272-RC, C1275, C1279, C1281, C1306, C1427, C1434, C1437, C144, C1446, C1461, C1476, C1501, C1507-M, C1511, C1529, C153, C1557, C1571, C1578, C158-RC, C1697, C1703, C1716, C1721, C1835, C1841, C1883, C189, C1903, C193, C2058, C2061, C3005, C3050, C3052a, C3053, C3055C3056, C3057, C3058, C3059, C3062, C3063, C3073, C3074, C3075, C3076, C3077, C3078, C3081, C3082, C3084, C3094, C3112, C3114, C3124, C3126, C3130, C3138, C3142, C3144, C3279, C601, C604, C605, C606-RC, C608, C609, C610, C613, C614, C616, C617, C618, C619, C620, C625, C626, C631, C633, C636, C640, C641, C647, C647-RC, C648, C651, C656, C666, C667, C669, C675, C676, C679, C680, C681, C682, C683, C684, C685, C689, C691, C692, C693, C694, C698, C699, C7084, C727, C744, C753, C774, C787, C800, C807, C808, C819, C855, C860, C863, C870, C873-RC, C878, C883-M, C886, C895-M, C904, C905, C906, C907-M, C911, C913, C916, C917-M, C922, C923-M, C926, C927, C928, C930, C933, C937, C938, C942, C943, C948, C949, C953-C, C953-M, C954, C955, C957-M, C970-M, C976, C982, C986, C987, S0607, S0970M, S1000, S1001, S1020, S1024, S1058, S1059, S1071, S1077, S1078, S1098, S1108, S1145, S1169-M, S1221-M, S1287, S1322, S1497, S1545, S1581, S1686, S271, S300, S418, S605, S615, S621, S622, S627, S628, S629, S630, S632, S634, S635, S637, S638, S639, S643, S644, S645, S646, S649, S649a, S650, S652, S653, S655, S657, S658, S659, S660, S661, S662, S663, S664, S668, S670, S671, S672, S674, S676, S677, S678, S686, S687, S696, S699, S700, S705, S732, S738, S746, S748, S766, S773, S779S766-RC, S791, S792, S798, S805-RC, S806, S814, S815, S816, S817, S818, S823, S824, S825, S829, S831, S838, S843, S845, S846, S846-M, S853, S854, S858, S859, S862, S863, S865-M, S867, S869, S874, S875, S879, S882, S884, S885-M, S891, S896, S900, S901, S901-M, S959, S964, S965, S969, S981, S988, S992, and S997. |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
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For Additional Information Contact | 847-501-1884 |
Manufacturer Reason for Recall | Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator. |
FDA Determined Cause 2 | Other |
Action | On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield. |
Quantity in Commerce | 309 systems (Domestic), 101 (Foreign) |
Distribution | Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAA
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