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.
This recall has been terminated (originally issued September 4, 2008).
- Recall Initiated
- May 21, 2008
- Posted
- September 4, 2008
- Terminated
- November 27, 2010
- Recall Number
- Z-2194-2008
- Quantity
- 241 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Dose delivery may be altered after import from a third party planning system during radiation therapy.
Distribution
US and to Canada, Australia, Bahrain, Belorussia, Colombia, Finland, Germany, Greece, India, Italy, Japan, Kuwait, Lithuania, Mexico, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and the UK.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.