Class 2 Device Recall Aria Radiation Oncology Version 8.1

• Date Initiated by Firm: May 21, 2008
• Date Posted: September 04, 2008
• Recall Status: Terminated on November 27, 2010
• Recall Number: Z-2194-2008
• Recall Event ID: 48652
• 510(K)Number: K001643
• Product Classification: Accelerator, Linear, Medical - Product Code IYE
• 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.
• Code Information: 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
• FEI Number: 2916710
• Recalling Firm/ Manufacturer: Varian Medical Systems Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: 650-424-5731
• Manufacturer Reason for Recall: Dose delivery may be altered after import from a third party planning system during radiation therapy.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 241 units
• 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.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = IYE