Varian Medical Systems Oncology Systems Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately. Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately.
Brand
Varian Medical Systems Oncology Systems
Lot Codes / Batch Numbers
Versions 8.1, serial numbers HIT0002, HIT0004M, HIT0005, HIT0028, HIT0043M, HIT0052, HIT0064, HIT0097M, HIT0467, HIT0468, HIT0480M, HIT0468, HIT0480M, HIT0486, HIT0487, HIT0490, HIT0492, HIT0507, HIT0860, HIT0863, HIT0864, HIT0870M, HIT0890, HIT0909, HIT0910, HIT0912, HIT1132, HIT1151, HIT1152, HIT1155, HIT1157, HIT1159, HIT1168, HIT1172, HIT1356, HIT1359, HIT1363, HIT1369, HIT1373, HIT1381, HIT1390, HIT1394, HIT1544, HIT1548, HIT1551, HIT1558, HIT1571, HIT1573, HIT1577, HIT0107, HIT0121, HIT0124, HIT0125, HIT0145, HIT0147, HIT0170, HIT0227, HIT0249, HIT0270, HIT0288, HIT0300, HIT0314, HIT0318, HIT0321, HIT0326, HIT0339, HIT0346, HIT0350, HIT0351, HIT0355M, HIT0368, HIT0378, HIT0381, HIT0396, HIT0401, HIT0402, HIT0414, HIT0416, HIT0419, HIT0426, HIT0436M, HIT0437, HIT0461, HIT0515, HIT0522, HIT0525M, HIT0547, HIT0565, HIT0587, HIT0588, HIT0624, HIT0633, HIT0650, HIT2651, HIT0660, HIT0671, HIT0681, HIT0682, HIT0689, HIT0711, HIT0712, HIT0739, HIT0750, HIT0754, HIT0771, HIT0782, HIT0787, HIT0797, HIT0804, HIT0810, HIT0812, HIT0840, HIT0843, HIT0844, HIT0848, HIT0856, HIT0858, HIT0925, HIT0944, HIT0949M, HIT0950, HIT0951, HIM, HIT0951R1, HIT2956, HIT0962, HIT0968, HIT0977, HIT0993, HIT1006, HIT1010, HIT1016, HIT1024, HIT1027, HIT1043, HIT1047, HIT1052, HIT1058, HIT1062, HIT1064, HIT1072, HIT1082, HIT1087, HIT1093, HIT1098, HIT1110M, HIT1115, HIT1116, HIT1121, HIT1122, HIT1128, HIT1190, HIT1200, HIT1208, HIT1215, HIT1216, HIT1225, HIT1231, HIT1235, HIT1243, HIT1245, HIT1247, HIT1250, HIT1252, HIT1260, HIT1264, HIT1267, HIT1269, HIT1273, HIT1275, HIT1277, HIT1278, HIT1284, HIT1288, HIT1296, HIT1298, HIT1303, HIT1306, HIT1315, HIT1317, HIT1321, HIT1323, HIT1329, HIT1343, HIT1353, HIT1398, HIT1399, HIT1402, HIT1404, HIT1410, HIT1413, HIT1415, HIT1421, HIT1423, HIT1426, HIT1432, HIT1433, HIT1435, HIT1438, HIT1443, HIT1444, HIT1451, HIT1458M, HIT1464, HIT1469, HIT1473, HIT1478, HIT1481, HIT1483, HIT1486, HIT1493, HIT1496, HIT1505, HIT1506, HIT1518M, HIT1521, HIT1526, HIT1539, HIT1541, HIT1579, HIT1584, HIT1592, HIT1594, HIT1597, HIT1599, HIT1604, HIT1606, HIT1614, HIT1616, HIT1623, HIT1626, HIT1628, HIT1632, HIT1635, HIT1639, HIT1644, HIT1658, HIT1660, HIT1662, HIT1678, HIT1679, and HIT1712
Products Sold
Versions 8.1, serial numbers HIT0002, HIT0004M, HIT0005, HIT0028, HIT0043M, HIT0052, HIT0064, HIT0097M, HIT0467, HIT0468, HIT0480M, HIT0468, HIT0480M, HIT0486, HIT0487, HIT0490, HIT0492, HIT0507, HIT0860, HIT0863, HIT0864, HIT0870M, HIT0890, HIT0909, HIT0910, HIT0912, HIT1132, HIT1151, HIT1152, HIT1155, HIT1157, HIT1159, HIT1168, HIT1172, HIT1356, HIT1359, HIT1363, HIT1369, HIT1373, HIT1381, HIT1390, HIT1394, HIT1544, HIT1548, HIT1551, HIT1558, HIT1571, HIT1573, HIT1577, HIT0107, HIT0121, HIT0124, HIT0125, HIT0145, HIT0147, HIT0170, HIT0227, HIT0249, HIT0270, HIT0288, HIT0300, HIT0314, HIT0318, HIT0321, HIT0326, HIT0339, HIT0346, HIT0350, HIT0351, HIT0355M, HIT0368, HIT0378, HIT0381, HIT0396, HIT0401, HIT0402, HIT0414, HIT0416, HIT0419, HIT0426, HIT0436M, HIT0437, HIT0461, HIT0515, HIT0522, HIT0525M, HIT0547, HIT0565, HIT0587, HIT0588, HIT0624, HIT0633, HIT0650, HIT2651, HIT0660, HIT0671, HIT0681, HIT0682, HIT0689, HIT0711, HIT0712, HIT0739, HIT0750, HIT0754, HIT0771, HIT0782, HIT0787, HIT0797, HIT0804, HIT0810, HIT0812, HIT0840, HIT0843, HIT0844, HIT0848, HIT0856, HIT0858, HIT0925, HIT0944, HIT0949M, HIT0950, HIT0951, HIM, HIT0951R1, HIT2956, HIT0962, HIT0968, HIT0977, HIT0993, HIT1006, HIT1010, HIT1016, HIT1024, HIT1027, HIT1043, HIT1047, HIT1052, HIT1058, HIT1062, HIT1064, HIT1072, HIT1082, HIT1087, HIT1093, HIT1098, HIT1110M, HIT1115, HIT1116, HIT1121, HIT1122, HIT1128, HIT1190, HIT1200, HIT1208, HIT1215, HIT1216, HIT1225, HIT1231, HIT1235, HIT1243, HIT1245, HIT1247, HIT1250, HIT1252, HIT1260, HIT1264, HIT1267, HIT1269, HIT1273, HIT1275, HIT1277, HIT1278, HIT1284, HIT1288, HIT1296, HIT1298, HIT1303, HIT1306, HIT1315, HIT1317, HIT1321, HIT1323, HIT1329, HIT1343, HIT1353, HIT1398, HIT1399, HIT1402, HIT1404, HIT1410, HIT1413, HIT1415, HIT1421, HIT1423, HIT1426, HIT1432, HIT1433, HIT1435, HIT1438, HIT1443, HIT1444, HIT1451, HIT1458M, HIT1464, HIT1469, HIT1473, HIT1478, HIT1481, HIT1483, HIT1486 , HIT1493, HIT1496, HIT1505, HIT1506, HIT1518M, HIT1521, HIT1526, HIT1539, HIT1541, HIT1579, HIT1584, HIT1592, HIT1594, HIT1597, HIT1599, HIT1604, HIT1606, HIT1614, HIT1616, HIT1623, HIT1626, HIT1628, HIT1632, HIT1635, HIT1639, HIT1644, HIT1658, HIT1660, HIT1662, HIT1678, HIT1679, and HIT1712
Varian Medical Systems Oncology Systems is recalling Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA T due to Dose delivery may be altered after import from a third party planning system during radiation therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dose delivery may be altered after import from a third party planning system during radiation therapy.
Recommended Action
Per FDA guidance
Recall was initiated on May 21, 2008. A product notification letter (sent via certified mail) was distributed to all affected users, with description of the problem i.e., dose delivery may be altered after import from a third party planning system during radiation therapy . The letter was also distributed to Varian Sites, Marketing and Service Organizations. A software upgrade is currently being developed. For assistance, contact Varian Medical Systems, Oncology Systems at 1-650-424-5731.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026