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U.S. Department of Health and Human Services

Class 2 Device Recall DRX Revolution Mobile XRay System

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 Class 2 Device Recall DRX Revolution Mobile XRay Systemsee related information
Date Initiated by FirmOctober 02, 2023
Date PostedDecember 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0437-2024
Recall Event ID 93241
510(K)NumberK191025 
Product Classification System, x-ray, mobile - Product Code IZL
ProductDRX Revolution Mobile X-Ray System
Code Information Catalog No. 1019397, 1023423, 1030717, 1030725, 1044726, 1060177, 8608754, 1023415, 8610180, 8618894; UDI-DI (01)60889971019394(21)2185, (01)60889971019394(21)2186, (01)60889971019394(21)2187, (01)60889971019394(21)2193, (01)60889971019394(21)2194, (01)60889971019394(21)2195, (01)60889971019394(21)2196, (01)60889971019394(21)2200, (01)60889971019394(21)2203, (01)60889971019394(21)2204, (01)60889971019394(21)2205, (01)60889971019394(21)2206, (01)60889971019394(21)2207, (01)60889971019394(21)2208, (01)60889971019394(21)2209, (01)60889971019394(21)2210, (01)60889971019394(21)2213, (01)60889971019394(21)2217, (01)60889971019394(21)2218, (01)60889971019394(21)2221, (01)60889971019394(21)2227, (01)60889971019394(21)2232, (01)60889971019394(21)2233, (01)60889971019394(21)2235, (01)60889971019394(21)2236, (01)60889971019394(21)2237, (01)60889971019394(21)2240, (01)60889971019394(21)2243, (01)60889971019394(21)2247, (01)60889971019394(21)2248, (01)60889971019394(21)2249, 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(01)60889971019394(21)3185, (01)60889971019394(21)3188, (01)60889971019394(21)3189, (01)60889971019394(21)3190, (01)60889971019394(21)3191, (01)60889971019394(21)3192, (01)60889971019394(21)3193, (01)60889971019394(21)3194, (01)60889971019394(21)3196, (01)60889971019394(21)3197, (01)60889971019394(21)3198, (01)60889971019394(21)3199, (01)60889971019394(21)3200, (01)60889971019394(21)3201, (01)60889971019394(21)3202, (01)60889971019394(21)3203, (01)60889971019394(21)3205, (01)60889971019394(21)3206, (01)60889971019394(21)3207, (01)60889971019394(21)3209, (01)60889971019394(21)3210, (01)60889971019394(21)3211, (01)60889971019394(21)3212, (01)60889971019394(21)3213, (01)60889971019394(21)3214, (01)60889971019394(21)3215, (01)60889971019394(21)3216, (01)60889971019394(21)3217, (01)60889971019394(21)3218, (01)60889971019394(21)3219, (01)60889971019394(21)3220, (01)60889971019394(21)3221, (01)60889971019394(21)3222, (01)60889971019394(21)3223, (01)60889971019394(21)3224, 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(01)60889971019394(21)3386, (01)60889971019394(21)3387, (01)60889971019394(21)3390, (01)60889971019394(21)3393, (01)60889971019394(21)3396, (01)60889971019394(21)3397, (01)60889971019394(21)3398, (01)60889971019394(21)3399, (01)60889971019394(21)3400, (01)60889971019394(21)3401, (01)60889971019394(21)3403, (01)60889971019394(21)3408, (01)60889971019394(21)3409, (01)60889971019394(21)3410, (01)60889971019394(21)3417, (01)60889971019394(21)3418, (01)60889971019394(21)3419, (01)60889971019394(21)3423, (01)60889971019394(21)3424, (01)60889971019394(21)3427, (01)60889971019394(21)3428, (01)60889971019394(21)3429, (01)60889971019394(21)3432, (01)60889971019394(21)3434, (01)60889971019394(21)3435, (01)60889971019394(21)3437, (01)60889971019394(21)3438, (01)60889971019394(21)3439, (01)60889971019394(21)3440, (01)60889971019394(21)3441, (01)60889971019394(21)3442, (01)60889971019394(21)3443, (01)60889971019394(21)3444, (01)60889971019394(21)3445, (01)60889971019394(21)3446, (01)60889971019394(21)3447, (01)60889971019394(21)3448, (01)60889971019394(21)3449, (01)60889971019394(21)3450, (01)60889971019394(21)3451, (01)60889971019394(21)3452, (01)60889971019394(21)3453, (01)60889971019394(21)3454, (01)60889971019394(21)3455, (01)60889971019394(21)3456, (01)60889971019394(21)3457, (01)60889971019394(21)3458, (01)60889971019394(21)3461, (01)60889971019394(21)3462, (01)60889971019394(21)3507, (01)60889971019394(21)3508, (01)60889971019394(21)3520, (01)60889971019394(21)3540, (01)60889971019394(21)3541, (01)60889971019394(21)3542, (01)60889971019394(21)3609, (01)60889971019394(21)4731, (01)60889971019394(21)4732, (01)60889971019394(21)4733, (01)60889971019394(21)4734, ;Serial No. 101, 111, 114, 119, 121, 122, 123, 124, 125, 126, 134, 151, 152, 153, 154, 155, 161, 162, 164, 165, 166, 167, 168, 169, 173, 174, 176, 177, 178, 180, 182, 183, 188, 190, 191, 192, 196, 198, 199, 200, 201, 202, 203, 205, 206, 207, 208, 211, 222, 223, 224, 225, 226, 227, 228, 230, 231, 235, 236, 237, 238, 239, 240, 241, 242, 243, 245, 246, 247, 248, 249, 254, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 275, 276, 279, 280, 281, 282, 283, 284, 285, 286, 305, 312, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 330, 332, 333, 334, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 353, 355, 357, 358, 359, 360, 361, 362, 364, 365, 375, 376, 379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 394, 395, 396, 397, 398, 399, 400, 401, 403, 404, 405, 411, 412, 413, 414, 415, 417, 420, 421, 423, 431, 432, 433, 434, 435, 441, 442, 443, 444, 451, 455, 456, 457, 458, 459, 460, 461, 464, 466, 467, 487, 488, 489, 490, 495, 498, 506, 510, 511, 512, 514, 515, 516, 517, 518, 519, 522, 524, 530, 538, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549, 555, 557, 560, 561, 562, 563, 564, 581, 583, 584, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 600, 601, 602, 603, 609, 610, 612, 613, 616, 619, 620, 621, 626, 627, 628, 629, 631, 632, 633, 634, 635, 636, 637, 639, 644, 645, 649, 650, 651, 657, 658, 659, 660, 662, 663, 664, 665, 676, 677, 678, 679, 680, 681, 682, 685, 686, 687, 688, 689, 690, 691, 692, 693, 694, 695, 696, 697, 699, 700, 701, 702, 703, 704, 705, 706, 707, 708, 709, 710, 711, 712, 713, 714, 715, 718, 721, 723, 724, 725, 727, 728, 729, 730, 731, 732, 733, 734, 735, 736, 740, 741, 745, 746, 747, 748, 749, 750, 751, 752, 753, 754, 760, 761, 762, 764, 765, 766, 767, 768, 773, 774, 777, 790, 791, 792, 796, 797, 798, 801, 802, 803, 806, 807, 808, 809, 810, 815, 816, 819, 821, 822, 823, 826, 827, 833, 834, 840, 841, 842, 844, 849, 850, 851, 852, 854, 863, 864, 865, 867, 868, 869, 870, 871, 872, 873, 874, 875, 876, 878, 879, 880, 890, 894, 895, 896, 897, 899, 900, 901, 903, 904, 905, 907, 913, 914, 915, 919, 920, 921, 922, 927, 928, 930, 931, 932, 935, 939, 940, 941, 942, 943, 944, 945, 956, 957, 958, 959, 961, 962, 963, 966, 967, 969, 975, 976, 977, 978, 979, 980, 982, 983, 984, 985, 986, 988, 990, 991, 992, 993, 994, 995, 996, 997, 998, 999, 1000, 1002, 1009, 1027, 1030, 1033, 1035, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1054, 1057, 1058, 1059, 1060, 1064, 1065, 1066, 1067, 1068, 1069, 1074, 1081, 1083, 1085, 1096, 1097, 1098, 1100, 1101, 1102, 1104, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1118, 1119, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1153, 1154, 1159, 1160, 1161, 1162, 1163, 1164, 1168, 1171, 1172, 1173, 1175, 1176, 1177, 1178, 1179, 1180, 1182, 1183, 1184, 1185, 1186, 1195, 1196, 1198, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1208, 1210, 1211, 1222, 1223, 1224, 1225, 1226, 1227, 1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1236, 1237, 1238, 1239, 1240, 1241, 1245, 1246, 1254, 1255, 1256, 1257, 1258, 1259, 1260, 1261, 1264, 1265, 1266, 1280, 1285, 1286, 1290, 1291, 1292, 1293, 1294, 1295, 1296, 1297, 1298, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1315, 1316, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1343, 1345, 1348, 1349, 1356, 1357, 1358, 1359, 1360, 1361, 1362, 1363, 1364, 1378, 1379, 1380, 1386, 1388, 1389, 1390, 1391, 1394, 1395, 1396, 1401, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1427, 1428, 1429, 1430, 1436, 1437, 1439, 1458, 1459, 1460, 1461, 1462, 1463, 1466, 1467, 1468, 1469, 1470, 1473, 1474, 1475, 1476, 1477, 1478, 1479, 1480, 1482, 1483, 1484, 1485, 1486, 1487, 1488, 1490, 1491, 1494, 1495, 1496, 1497, 1498, 1499, 1500, 1503, 1504, 1505, 1506, 1507, 1510, 1511, 1512, 1514, 1524, 1529, 1530, 1537, 1538, 1539, 1540, 1542, 1544, 1545, 1546, 1549, 1550, 1551, 1552, 1553, 1555, 1556, 1557, 1558, 1559, 1561, 1568, 1569, 1570, 1571, 1573, 1574, 1575, 1591, 1592, 1593, 1595, 1596, 1597, 1604, 1605, 1606, 1607, 1608, 1610, 1611, 1612, 1613, 1614, 1615, 1616, 1617, 1618, 1619, 1620, 1621, 1622, 1623, 1624, 1625, 1637, 1638, 1642, 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1927, 1928, 1929, 1933, 1934, 1935, 1936, 1937, 1938, 1939, 1940, 1941, 1943, 1945, 1946, 1947, 1949, 1950, 1954, 1956, 1957, 1959, 1960, 1964, 1966, 1968, 1969, 1970, 1971, 1981, 1982, 1983, 1984, 1985, 1986, 1988, 1989, 1990, 1996, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2011, 2012, 2014, 2015, 2016, 2017, 2020, 2021, 2022, 2024, 2026, 2027, 2028, 2043, 2044, 2045, 2046, 2048, 2051, 2052, 2058, 2059, 2060, 2061, 2062, 2063, 2072, 2073, 2075, 2076, 2077, 2078, 2079, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2089, 2090, 2091, 2093, 2094, 2097, 2098, 2102, 2103, 2104, 2105, 2106, 2107, 2108, 2110, 2111, 2113, 2114, 2115, 2118, 2119, 2120, 2121, 2122, 2123, 2124, 2125, 2126, 2127, 2129, 2132, 2133, 2134, 2136, 2137, 2138, 2143, 2144, 2145, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2160, 2162, 2163, 2164, 2165, 2168, 2169, 2173, 2174, 2175, 2176, 2177, 2178, 2179, 2180, 2181, 2182, 2183, 2185, 2186, 2187, 2193, 2194, 2195, 2196, 2200, 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Recalling Firm/
Manufacturer
Carestream Health, Inc.
1049 W Ridge Rd
Rochester NY 14615-2731
For Additional Information ContactCustomer Care Center
1-800-328-2910
Manufacturer Reason
for Recall
Unexpected failure of electrical components within the CPI generator.
FDA Determined
Cause 2
Component design/selection
ActionConsignees were sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" on 10/02/2023. This notice requested that consignees inform all personnel that utilize the affected devices of the recall notice and to return the provided Consignee Notification Acknowledgement form completed. If a failure similar to the one associated with this recall event were to occur, users should move the system away from patients and staff, the system should be identified as inoperable, and a call should be made to Carestream Customer Care at 1-800-328-2910, your local service support number, or your Carestream Health Authorized Representative to schedule a service call. Customers with any questions are to call the Carestream Customer Care Center. If you have any questions or concerns please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24-hour basis. Outside of the U.S., please call your local Carestream Service support number.
Quantity in Commerce3,961 units
DistributionWorldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Rep., Finland, France, Germany, Ghana, Great Britain, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Monaco, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, & Vietnam.
Total Product Life CycleTPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZL
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