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U.S. Department of Health and Human Services

Class 2 Device Recall Image Database

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  Class 2 Device Recall Image Database see related information
Date Initiated by Firm May 17, 2011
Date Posted July 08, 2011
Recall Status1 Terminated 3 on March 15, 2012
Recall Number Z-2763-2011
Recall Event ID 58974
510(K)Number K093527  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARIA, versions 8.0 and 8.1;
Varian Medical Systems, Palo Alto, CA.

Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.
Code Information Model Number HIT-INFSYS: Serial Numbers: HIT0001 HIT0475 HIT1027 HIT1454 HIT1987 HIT2863 HIT3483 HIT3837 HIT0013 HIT0503M HIT1043 HIT1460 HIT2016 HIT2894M HIT3505 HIT3852 HIT0025 HIT0503R1 HIT1052 HIT1462 HIT2020 HIT2894R1 HIT3509 HIT3854 HIT0040 HIT0513 HIT1060 HIT1466 HIT2068 HIT2894R2 HIT3513 HIT3865 HIT0055 HIT0516 HIT1062 HIT1478 HIT2074 HIT2900 HIT3516 HIT3867 HIT0059 HIT0522 HIT1066 HIT1492 HIT2076 HIT2909 HIT3519 HIT3871 HIT0066 HIT0539 HIT1087 HIT1498M HIT2101M HIT2930 HIT3524 HIT3875 HIT0072 HIT0563 HIT1095 HIT1498R1 HIT2101R1 HIT2954 HIT3525 HIT3876 HIT0076 HIT0568M HIT1129 HIT1507 HIT2126 HIT2965 HIT3539 HIT3888 HIT0082 HIT0568R1 HIT1132M HIT1516M HIT2164 HIT3010 HIT3563M HIT3902 HIT0095 HIT0585M HIT1132R1 HIT1516R1 HIT2190M HIT3018 HIT3563R1 HIT3904 HIT0100 HIT0585R1 HIT1152 HIT1521 HIT2190R1 HIT3045 HIT3564 HIT3908 HIT0139M HIT0606M HIT1170 HIT1551 HIT2226 HIT3112 HIT3587 HIT3910 HIT0139R1 HIT0606R1 HIT1211 HIT1558 HIT2278 HIT3116M HIT3588 HIT3911 HIT0140 HIT0613 HIT1212 HIT1563 HIT2317 HIT3116R1 HIT3598M HIT3913 HIT0167 HIT0627 HIT1225 HIT1581 HIT2409M HIT3126 HIT3598R1 HIT3920 HIT0183 HIT0633 HIT1227 HIT1602M HIT2409R1 HIT3174 HIT3598R2 HIT3923 HIT0185 HIT0647 HIT1231 HIT1602R1 HIT2411 HIT3179 HIT3607 HIT3925 HIT0199 HIT0668 HIT1241 HIT1642 HIT2414M HIT3192M HIT3614 HIT3927 HIT0215 HIT0701 HIT1245 HIT1703 HIT2414R1 HIT3192R1 HIT3624 HIT3928 HIT0234 HIT0737 HIT1267 HIT1725 HIT2431 HIT3198 HIT3627 HIT3939 HIT0244 HIT0747 HIT1269 HIT1745 HIT2529 HIT3209 HIT3628 HIT3941 HIT0265 HIT0777M HIT1284 HIT1751 HIT2555 HIT3219 HIT3629 HIT3954 HIT0268 HIT0777R1 HIT1298 HIT1765 HIT2595 HIT3233 HIT3630 HIT3955 HIT0269 HIT0792 HIT1318 HIT1811 HIT2603 HIT3242 HIT3635 HIT3964 HIT0293 HIT0813 HIT1321 HIT1812 HIT2623A1 HIT3261 HIT3642 HIT3984 HIT0303 HIT0827 HIT1325 HIT1820 HIT2623M HIT3267 HIT3664 HIT3989 HIT0318M HIT0851 HIT1327 HIT1839 HIT2623R1 HIT3298M HIT3677 HIT3998 HIT0318R1 HIT0866 HIT1329 HIT1845 HIT2623R2 HIT3298R1 HIT3679 HIT4001 HIT0319M HIT0868 HIT1332 HIT1852 HIT2670 HIT3298R2 HIT3720 HIT4003 HIT0319R1 HIT0886 HIT1338 HIT1854 HIT2688 HIT3298R3 HIT3724 HIT4009 HIT0339M HIT0892 HIT1348 HIT1860 HIT2716 HIT3338 HIT3741M HIT4015 HIT0339R1 HIT0930 HIT1361 HIT1867 HIT2743 HIT3354 HIT3741R1 HIT4016 HIT0348 HIT0933 HIT1380 HIT1882 HIT2745 HIT3365 HIT3744 HIT4027 HIT0365 HIT0948A1 HIT1381 HIT1889 HIT2746 HIT3370 HIT3752 HIT4034 HIT0404 HIT0948M HIT1394 HIT1903 HIT2747 HIT3386 HIT3754 HIT4038 HIT0405 HIT0948R1 HIT1397 HIT1904M HIT2749 HIT3391 HIT3759 HIT4040 HIT0427 HIT0951M HIT1404 HIT1904R1 HIT2777 HIT3397 HIT3764M HIT4043 HIT0444 HIT0951R1 HIT1408 HIT1921 HIT2826 HIT3400 HIT3764R1 HIT4071 HIT0450 HIT0952 HIT1415 HIT1925 HIT2842 HIT3404M HIT3792 HIT4075 HIT0459 HIT0967 HIT1420 HIT1951 HIT2844 HIT3404R1 HIT3799 HIT4078 HIT0474M HIT0979 HIT1436 HIT1965 HIT2846 HIT3425 HIT3801 HIT4090 HIT0474R1 HIT0982M HIT1440 HIT1967 HIT2848 HIT3454 HIT3813  HIT0474R2 HIT0982R1 HIT1444 HIT1980M HIT2856M HIT3470M HIT3822  HIT0474R3 HIT1022 HIT1452 HIT1980R1 HIT2856R1 HIT3470R1 HIT3823   ***12-20-12, AMENDED INFO ***: H1T0726 
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall
An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes.
FDA Determined
Cause 2
Software design
Action Varian Medical Systems, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265. ***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.***
Quantity in Commerce 357
Distribution Worldwide Distribution -- USA (nationwide) and countries of Algeria, Australia, Austria, Belgium, Brazil, Chile, China, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan Jordan, Kuwait, Malaysia, Morocco, Netherlands, Oman, Pakistan, Panama, Portugal, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunsia, Turkey, Ukraine, United Arab Emirates, and 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.
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