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U.S. Department of Health and Human Services

Class 2 Device Recall ARIA, RT Chart Application v 8.0 through 8.9

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  Class 2 Device Recall ARIA, RT Chart Application v 8.0 through 8.9 see related information
Date Initiated by Firm March 09, 2011
Date Posted May 02, 2011
Recall Status1 Terminated 3 on March 13, 2012
Recall Number Z-2125-2011
Recall Event ID 58424
510(K)Number K093527  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARIA, RT Chart Application v 8.0 through 8.9

Varian Medical Systems, Palo Alto, CA.
Aria Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment.
Code Information Model number HIT-INFSYS;  Codes: HIT0001 HIT0097R3 HIT0190R3 HIT0297 HIT0380 HIT0465 HIT0558 HIT0667 HIT0771 HIT0860 HIT0002 HIT0097R4 HIT0191R1 HIT0300 HIT0381 HIT0467 HIT0565 HIT0668 HIT0773M HIT0863 HIT0003 HIT0100 HIT0196 HIT0301 HIT0383 HIT0468M HIT0572 HIT0671 HIT0773R1 HIT0864 HIT0004R1 HIT0101 HIT0198M HIT0304 HIT0388 HIT0468R1 HIT0573 HIT0673 HIT0776 HIT0869 HIT0004R2 HIT0103 HIT0198R1 HIT0306 HIT0390 HIT0470 HIT0579M HIT0681 HIT0777M HIT0870M HIT0005 HIT0107 HIT0199 HIT0307 HIT0393 HIT0477M HIT0579R1 HIT0682 HIT0777R1 HIT0870R1 HIT0021 HIT0109 HIT0202 HIT0308M HIT0397 HIT0477R1 HIT0583 HIT0685M HIT0781 HIT0870R2 HIT0023 HIT0114 HIT0203 HIT0308R1 HIT0399M HIT0480M HIT0587 HIT0689M HIT0782 HIT0870R3 HIT0025 HIT0115 HIT0204 HIT0311 HIT0399R1 HIT0480R1 HIT0588 HIT0689R1 HIT0784M HIT0872 HIT0027 HIT0116 HIT0206 HIT0312 HIT0401 HIT0481 HIT0590 HIT0691M HIT0784R1 HIT0874 HIT0028 HIT0118 HIT0207 HIT0313 HIT0402 HIT0483 HIT0592 HIT0691R1 HIT0784R2 HIT0880 HIT0029 HIT0120 HIT0210 HIT0314 HIT0405 HIT0485 HIT0593 HIT0691R2 HIT0784R3 HIT0881 HIT0030 HIT0121 HIT0211 HIT0315 HIT0406 HIT0486 HIT0594 HIT0693M HIT0784R4 HIT0885 HIT0031M HIT0122 HIT0212 HIT0316 HIT0407 HIT0487 HIT0606M HIT0693R1 HIT0787 HIT0889 HIT0031R1 HIT0123M HIT0213 HIT0317 HIT0409 HIT0489M HIT0606R1 HIT0696 HIT0790 HIT0892 HIT0032 HIT0123R1 HIT0214 HIT0319 HIT0411M HIT0489R1 HIT0610 HIT0697 HIT0792 HIT0896 HIT0038 HIT0124 HIT0225 HIT0323 HIT0414 HIT0490 HIT0613 HIT0699 HIT0795 HIT0898 HIT0041 HIT0125 HIT0227 HIT0326 HIT0416 HIT0492 HIT0614 HIT0701 HIT0799 HIT0900M HIT0043M HIT0126 HIT0229 HIT0328M HIT0419 HIT0494 HIT0616 HIT0705 HIT0801 HIT0900R1 HIT0043R1 HIT0134 HIT0231 HIT0328R1 HIT0420 HIT0495 HIT0617 HIT0714 HIT0804 HIT0901 HIT0043R2 HIT0137 HIT0234 HIT0328R2 HIT0422 HIT0498 HIT0624 HIT0718 HIT0805 HIT0905M HIT0043R3 HIT0138 HIT0236 HIT0329 HIT0424 HIT0499 HIT0629M HIT0721 HIT0808M HIT0905R1 HIT0045 HIT0144 HIT0238 HIT0331 HIT0426 HIT0501 HIT0629R1 HIT0723M HIT0808R1 HIT0907 HIT0047 HIT0145 HIT0242 HIT0337M HIT0427 HIT0509 HIT0629R2 HIT0723R1 HIT0812 HIT0909 HIT0050 HIT0147 HIT0244 HIT0339 HIT0428 HIT0510 HIT0632M HIT0726 HIT0814M HIT0911 HIT0052 HIT0148 HIT0246 HIT0341M HIT0430 HIT0511 HIT0632R1 HIT0733 HIT0814R1 HIT0912 HIT0055 HIT0150 HIT0249 HIT0342 HIT0432M HIT0512 HIT0633 HIT0736 HIT0816 HIT0916 HIT0057 HIT0154 HIT0251M HIT0344 HIT0432R1 HIT0515 HIT0637 HIT0738M HIT0818M HIT0918M HIT0059 HIT0155 HIT0254 HIT0351 HIT0434M HIT0516 HIT0639 HIT0738R1 HIT0818R1 HIT0918R1 HIT0061 HIT0162 HIT0255 HIT0353 HIT0434R1 HIT0517 HIT0641M HIT0739M HIT0818R2 HIT0922 HIT0066 HIT0165M HIT0262 HIT0355M HIT0436M HIT0519 HIT0641R1 HIT0739R1 HIT0825 HIT0924 HIT0068 HIT0165R1 HIT0264M HIT0355R1 HIT0436R1 HIT0520M HIT0642 HIT0740 HIT0828 HIT0926 HIT0070 HIT0167 HIT0264R1 HIT0357 HIT0437 HIT0525M HIT0643 HIT0742M HIT0829 HIT0928 HIT0072 HIT0170M HIT0264R3 HIT0359 HIT0441 HIT0525R1 HIT0645 HIT0742R1 HIT0833 HIT0937 HIT0074M HIT0170R2 HIT0265 HIT0361M HIT0442 HIT0525R2 HIT0647 HIT0746 HIT0835 HIT0938 HIT0076 HIT0170R3 HIT0266 HIT0361R1 HIT0443 HIT0528 HIT0649 HIT0748 HIT0843 HIT0940 HIT0077 HIT0171 HIT0267M HIT0361R2 HIT0446 HIT0531 HIT0650 HIT0750 HIT0844 HIT0946 HIT0079M HIT0177R1 HIT0268 HIT0363 HIT0448 HIT0533 HIT0651 HIT0754 HIT0846 HIT0949M HIT0079R2 HIT0179 HIT0270 HIT0366M HIT0452 HIT0535 HIT0653 HIT0756R1 HIT0848 HIT0949R1 HIT0079R3 HIT0181 HIT0274 HIT0366R1 HIT0454 HIT0540 HIT0657 HIT0757 HIT0850 HIT0949R2 HIT0088 HIT0182 HIT0284 HIT0368 HIT0456 HIT0544 HIT0658 HIT0759 HIT0852 HIT0950 HIT0092 HIT0183 HIT0286 HIT0373M HIT0458 HIT0547 HIT0660 HIT0760 HIT0854 HIT0951M HIT0097M HIT0185 HIT0288 HIT0373R1 HIT0459 HIT0549 HIT0662 HIT0762 HIT0856 HIT0951R1 HIT0097R1 HIT0187 HIT0293 HIT0374 HIT0461 HIT0553 HIT0663 HIT0764 HIT0857 HIT0956 HIT0097R2 HIT0190R2 HIT0295 HIT0378 HIT0462 HIT0556 HIT0665 HIT0769 HIT0858 HIT0960  HIT0962 HIT1065 HIT1149R1 HIT1278 HIT1379 HIT1460 HIT1567 HIT1620R6 HIT1735 HIT1875 HIT0963 HIT1066 HIT1151 HIT1281M HIT1381 HIT1462 HIT1571 HIT1622 HIT1738 HIT1876 HIT0965 HIT1069 HIT1152 HIT1281R1 HIT1383 HIT1464 HIT1573 HIT1623 HIT1741 HIT1885 HIT0968 HIT1070 HIT1155 HIT1284 HIT1386 HIT1467 HIT1574 HIT1626 HIT1742R1 HIT1887 HIT0977 HIT1072 HIT1157 HIT1288 HIT1390 HIT1469 HIT1575 HIT1628 HIT1745 HIT1888 HIT0978 HIT1074 HIT1159 HIT1290 HIT1392 HIT1473 HIT1577 HIT1629M HIT1747M HIT1890 HIT0981 HIT1076M HIT1163 HIT1293 HIT1394 HIT1478 HIT1584 HIT1629R1 HIT1753 HIT1896 HIT0983M HIT1076R1 HIT1164 HIT1296 HIT1397 HIT1481 HIT1587M HIT1632 HIT1757 HIT1898 HIT0983R1 HIT1076R2 HIT1168 HIT1300 HIT1398 HIT1486 HIT1587R1 HIT1633 HIT1758 HIT1899 HIT0983R2 HIT1076R3 HIT1172 HIT1301 HIT1399 HIT1489 HIT1587R2 HIT1635 HIT1760 HIT1900 HIT0986M HIT1076R4 HIT1174 HIT1303 HIT1400 HIT1492 HIT1587R3 HIT1639 HIT1761 HIT1903 HIT0986R1 HIT1077 HIT1176 HIT1306 HIT1401 HIT1496 HIT1587R4 HIT1642 HIT1763 HIT1905 HIT0989 HIT1080 HIT1179M HIT1308 HIT1402 HIT1497M HIT1589M HIT1644 HIT1764M HIT1911 HIT0993 HIT1082 HIT1179R1 HIT1310 HIT1404 HIT1497R1 HIT1589R1 HIT1649 HIT1764R1 HIT1913 HIT0994 HIT1084 HIT1179R2 HIT1311 HIT1406 HIT1499M HIT1589R2 HIT1653 HIT1767 HIT1914 HIT0996 HIT1085 HIT1186 HIT1313 HIT1408 HIT1499R1 HIT1589R3 HIT1658 HIT1770 HIT1916 HIT0998 HIT1087 HIT1188 HIT1315 HIT1410 HIT1500M HIT1589R4 HIT1660M HIT1771 HIT1918 HIT1000 HIT1092 HIT1189 HIT1317 HIT1413 HIT1500R1 HIT1589R5 HIT1660R1 HIT1780 HIT1921 HIT1004 HIT1093 HIT1190 HIT1318 HIT1414M HIT1500R2 HIT1589R6 HIT1660R2 HIT1782 HIT1922 HIT1006 HIT1098 HIT1200 HIT1321 HIT1414R1 HIT1500R3 HIT1589R7 HIT1660R3 HIT1788 HIT1930 HIT1007 HIT1102 HIT1203 HIT1323 HIT1414R2 HIT1500R4 HIT1589R8 HIT1662 HIT1794 HIT1932 HIT1010 HIT1103 HIT1206 HIT1325 HIT1415 HIT1505 HIT1589R9 HIT1665 HIT1795 HIT1938M HIT1015 HIT1107 HIT1208 HIT1327 HIT1418 HIT1506 HIT1591 HIT1667 HIT1799 HIT1938R1 HIT1016 HIT1110M HIT1213 HIT1329 HIT1421 HIT1511 HIT1592 HIT1669 HIT1803 HIT1941 HIT1018 HIT1110R1 HIT1216 HIT1332 HIT1423 HIT1512M HIT1599 HIT1671 HIT1804M HIT1955M HIT1022 HIT1111 HIT1220M HIT1336 HIT1426 HIT1512R1 HIT1601 HIT1677 HIT1804R1 HIT1955R1 HIT1024 HIT1112 HIT1220R1 HIT1339R1 HIT1428 HIT1520 HIT1602M HIT1678 HIT1806 HIT1958 HIT1030 HIT1115 HIT1220R2 HIT1339R2 HIT1429 HIT1521 HIT1602R1 HIT1681 HIT1808 HIT1961 HIT1035 HIT1116 HIT1220R3 HIT1343 HIT1430M HIT1523M HIT1604 HIT1687 HIT1817 HIT1970M HIT1036 HIT1117 HIT1220R4 HIT1344M HIT1430R1 HIT1523R1 HIT1606 HIT1690 HIT1822 HIT1970R1 HIT1039 HIT1119M HIT1225 HIT1344R1 HIT1430R2 HIT1526 HIT1608R1 HIT1696 HIT1825 HIT1973 HIT1041 HIT1120 HIT1227 HIT1344R2 HIT1432 HIT1529 HIT1609M HIT1698 HIT1827 HIT1975 HIT1043 HIT1121 HIT1229 HIT1346M HIT1433 HIT1531 HIT1609R1 HIT1700 HIT1829 HIT1976 HIT1044 HIT1122 HIT1231 HIT1346R1 HIT1435 HIT1537 HIT1610M HIT1701R1 HIT1830 HIT1977 HIT1046 HIT1124 HIT1234 HIT1347 HIT1438 HIT1539 HIT1610R2 HIT1701R2 HIT1833 HIT1978 HIT1047 HIT1128 HIT1241 HIT1348 HIT1440 HIT1541 HIT1611M HIT1701R3 HIT1839 HIT1981 HIT1049 HIT1137 HIT1243 HIT1353M HIT1443 HIT1544 HIT1611R1 HIT1701R4 HIT1840 HIT1982 HIT1050 HIT1139 HIT1245 HIT1353R1 HIT1444 HIT1548 HIT1612M HIT1707 HIT1845 HIT1987 HIT1052 HIT1141 HIT1247 HIT1354 HIT1446 HIT1549 HIT1612R1 HIT1709 HIT1848 HIT1988 HIT1053 HIT1142M HIT1250 HIT1356 HIT1448M HIT1551 HIT1613 HIT1711 HIT1850 HIT1989 HIT1054 HIT1142R1 HIT1252M HIT1359 HIT1448R1 HIT1553 HIT1616 HIT1712 HIT1857 HIT1991 HIT1056M HIT1142R2 HIT1260 HIT1361 HIT1450 HIT1557 HIT1617 HIT1716 HIT1859 HIT1997M HIT1056R1 HIT1144 HIT1264 HIT1363M HIT1451 HIT1558 HIT1619 HIT1718 HIT1861 HIT1997R1 HIT1056R2 HIT1145M HIT1267 HIT1363R1 HIT1452 HIT1560M HIT1620M HIT1723 HIT1863 HIT1998 HIT1058 HIT1145R1 HIT1269 HIT1365 HIT1454 HIT1560R1 HIT1620R1 HIT1724 HIT1866 HIT2000 HIT1059 HIT1145R2 HIT1273 HIT1369 HIT1456 HIT1560R2 HIT1620R2 HIT1726 HIT1870M HIT2002 HIT1062 HIT1145R3 HIT1275 HIT1373 HIT1458M HIT1560R3 HIT1620R3 HIT1729 HIT1870R1 HIT2004 HIT1064 HIT1149M HIT1277 HIT1376 HIT1458R1 HIT1563 HIT1620R5 HIT1733 HIT1871R1 HIT2005M     HIT2005R1 HIT2105 HIT2269 HIT2385 HIT2559 HIT2830 HIT3088M HIT3355 HIT2005R2 HIT2109 HIT2271 HIT2388 HIT2561 HIT2834 HIT3091 HIT3362M HIT2005R3 HIT2110 HIT2273M HIT2392 HIT2563M HIT2835 HIT3092 HIT3362R1 HIT2005R4 HIT2111R1 HIT2275M HIT2400 HIT2563R1 HIT2843 HIT3110 HIT3407 HIT2006 HIT2111R2 HIT2275R1 HIT2402 HIT2565 HIT2860 HIT3112 HIT3412 HIT2009 HIT2111R3 HIT2275R2 HIT2409M HIT2567 HIT2865 HIT3121 HIT3424 HIT2012 HIT2112 HIT2275R3 HIT2409R1 HIT2572 HIT2875 HIT3127 HIT3428 HIT2013 HIT2113M HIT2275R4 HIT2417 HIT2574M HIT2878 HIT3128 HIT3456 HIT2014 HIT2113R2 HIT2279 HIT2422 HIT2576 HIT2880 HIT3135 HIT3464 HIT2016 HIT2115 HIT2282 HIT2424 HIT2584 HIT2884 HIT3147 HIT3466M HIT2017 HIT2117 HIT2283M HIT2425 HIT2588 HIT2889 HIT3154 HIT3466R1 HIT2021 HIT2131 HIT2283R1 HIT2432M HIT2596 HIT2891 HIT3157M  HIT2025 HIT2135 HIT2287 HIT2432R1 HIT2600 HIT2892 HIT3160  HIT2027 HIT2136 HIT2289 HIT2432R2 HIT2609 HIT2895 HIT3162  HIT2028 HIT2145 HIT2291M HIT2432R3 HIT2620 HIT2897 HIT3165  HIT2031 HIT2146 HIT2291R1 HIT2432R4 HIT2633 HIT2899 HIT3173  HIT2037R1 HIT2151 HIT2291R2 HIT2439 HIT2637 HIT2902 HIT3177  HIT2037R10 HIT2152 HIT2291R3 HIT2448 HIT2640M HIT2908M HIT3188  HIT2037R11 HIT2156 HIT2291R5 HIT2449M HIT2647 HIT2908R1 HIT3194  HIT2037R12 HIT2158 HIT2291R6 HIT2449R1 HIT2649 HIT2915 HIT3206  HIT2037R13 HIT2159 HIT2293 HIT2453 HIT2657 HIT2932 HIT3216  HIT2037R2 HIT2162 HIT2296 HIT2463M HIT2659 HIT2934 HIT3221R1  HIT2037R3 HIT2164 HIT2298 HIT2464 HIT2662 HIT2941 HIT3221R2  HIT2037R4 HIT2180 HIT2299R1 HIT2469 HIT2666 HIT2942 HIT3224  HIT2037R5 HIT2183 HIT2299R3 HIT2471M HIT2686 HIT2945 HIT3230  HIT2037R6 HIT2185 HIT2299R4 HIT2471R1 HIT2690 HIT2950 HIT3239  HIT2037R7 HIT2202 HIT2299R6 HIT2471R2 HIT2701M HIT2966 HIT3241  HIT2037R8 HIT2204 HIT2301 HIT2477M HIT2701R1 HIT2973 HIT3244  HIT2037R9 HIT2208M HIT2305 HIT2477R1 HIT2710M HIT2974 HIT3245  HIT2041 HIT2208R2 HIT2314 HIT2477R3 HIT2710R1 HIT2975 HIT3250  HIT2042 HIT2208R3 HIT2325 HIT2480 HIT2711 HIT2977 HIT3251  HIT2044 HIT2208R4 HIT2326 HIT2484 HIT2724 HIT2981 HIT3257  HIT2049 HIT2208R5 HIT2329 HIT2491 HIT2726 HIT2992 HIT3264  HIT2058 HIT2208R7 HIT2331 HIT2502 HIT2731 HIT2995 HIT3268  HIT2063 HIT2209 HIT2337M HIT2506 HIT2732 HIT3019 HIT3277  HIT2064 HIT2218 HIT2341 HIT2509 HIT2737 HIT3020 HIT3282  HIT2067 HIT2219 HIT2345 HIT2512M HIT2739 HIT3025 HIT3293  HIT2069 HIT2231 HIT2346M HIT2512R1 HIT2752 HIT3033 HIT3295  HIT2078 HIT2236 HIT2346R1 HIT2513 HIT2754 HIT3040 HIT3296  HIT2079 HIT2237M HIT2353 HIT2519 HIT2757 HIT3048 HIT3299M  HIT2083 HIT2241 HIT2358 HIT2522 HIT2763 HIT3055 HIT3299R1  HIT2085 HIT2245 HIT2362M HIT2523 HIT2764 HIT3057 HIT3308  HIT2088 HIT2252 HIT2362R2 HIT2528 HIT2766 HIT3058 HIT3309  HIT2089 HIT2256 HIT2364 HIT2533 HIT2774 HIT3059 HIT3320  HIT2091 HIT2263 HIT2367 HIT2535 HIT2788 HIT3072 HIT3324  HIT2100 HIT2265 HIT2376 HIT2537 HIT2797 HIT3074 HIT3326  HIT2101M HIT2267M HIT2378 HIT2541 HIT2818 HIT3077 HIT3344  HIT2102 HIT2267R1 HIT2383 HIT2544 HIT2823 HIT3084 HIT3349;  ***12-20-12, AMENDED INFO ***: HIT2051, HIT1852, HIT1494, HIT3652, HIT2716, HIT0348, HIT2825, HIT0513           
Recalling Firm/
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
Manufacturer Reason
for Recall
An issue was identified with the gantry rotation direction when creating opposing field within the RT Chart function of ARIA, or possibly with third party planning systems and delivering the plan at 4DITC.
FDA Determined
Cause 2
Software design
Action Varian Medical Systems, Inc. Oncology Systems sent Urgent Medical Device Correction Field Safety Notice letters on March 9, 2011, to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters identifeid the product, the problem, and the action to be taken by the customer. Customers were instructed to: Manually enter the gantry angel 0.0 when the plan indicates angel 0.0. Manual entry is only allowed to one decimal place, so the range that triggers the issue cannot be created if the keyboard is ued to enter the gantry angel. Users with third party plan sources should verify whether gantry angles with two or more decimal places are supported. If so, customers may be affected by this issue, and should take steps suited to the device. In all cases, the display at the Treatment console is indicative of what direction the gantry will move - users are advised to be especially attentive to these values, particulary when non-zero couch rotation values are used. Users are advised to always run a simulation of the plan, including all plan motions, at the treatment unit prior to first patient treatment. For further clarification customers were insturcted to contact their local Varian Customer Support District Manager. For questions regarding this recall call 650-424-6471.
Quantity in Commerce 612 units
Distribution Worldwide Distribution - USA including CA, DC, FL, GA, MD, MN, MS, NY, OH, and TN and the countries of Canada, Australia, Austria, Bahrain, Bagladesh, Belarus, Belgium, Brazil, Columbia, Costa Rica, Cypress, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Luxemborg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tobago, Tunisia, Turkey, Ukraine, Emirates, and the United Kingdom.
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 and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.