Z-2194-2008

Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device...

Name: Z-2194-2008 Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device...
Creator: Varian Medical Systems Oncology Systems
Published: 2008-05-21
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-05-21 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of 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... on 2008-05-21. The reason FDA records is "Dose delivery may be altered after import from a third party planning system during radiation therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2194-2008
Status: Terminated
Initiated: 2008-05-21
Posted: 2008-09-04
Terminated: 2010-11-27
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Dose delivery may be altered after import from a third party planning system during radiation therapy.
Root cause tag: software
FDA root 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.
Product codes and lots: 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

Product code IYE

K001643Class IIVaris 1.4GVarian Medical Systems, Inc. / cleared 2000-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)