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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse Treatment Planning System

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 Class 2 Device Recall Eclipse Treatment Planning System see related information
Date Posted December 20, 2013
Recall Status1 Terminated on March 13, 2015
Recall Number Z-0552-2014
Recall Event ID 66956
510(K)Number K131807  K093527 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Plan Parameters workspace within
Eclipse Treatment Planning System Version 11 and 13;
ARIA Radiation Oncology versions 11 and 13
Acuity, versions 11 and 13.

Manufactured by Varian Medical Systems
Palo Alto, CA.

Used in radiation therapy simulation.
Code Information Model numbers H48, HIT, H77:
Code numbers:
H480001 H480164 H480362 H480544 H480717 H480969 H481133 H481323 H481504 H48179S H481969 H482027 H48208S
H480004 H48016S H48036S H48054S H48072S H480972 H481134 H481326 H481SOS H481796 H481970 H482028 H482086
H480009 H480174 H480373 H480546 H480727 H480974 H481138 H481327 H481506 H481804 H481971 H482029 H482087
H480010 H480175 H480374 H480547 H480760 H480975 H48114S H481328 H481510 H48180S H481972 H482030 H482088
H480011 H480176 H480378 H480548 H480764 H480980 H481146 H481329 H48152S H481806 H481973 H482031 H482089
H48001S H480181 H480379 H480566 H480765 H480981 H481147 H481334 H481532 H481807 H481974 H482032 H482090
H480030 H480182 H480380 H480578 H480766 H480989 H481148 H48133S H481533 H481815 H481975 H482033 H482091
H480033 H480200 H480381 H480579 H480767 H480992 H481153 H481343 H481540 H481816 H481976 H482034 H482092
H480034 H480207 H480382 H480580 H480769 H480994 H481154 H481352 H481543 H481834 H481977 H482035 H482093
H480035 H480208 H480384 H480581 H480770 H480996 H481155 H481353 H481544 H481835 H481978 H482036 H482094
H480036 H480209 H480404 H480582 H480774 H480997 H481156 H481354 H481545 H481836 H481979 H482037 H482095
H480037 H480210 H480405 H480590 H480782 H480998 H481164 H4813SS H481581 H481837 H481980 H482038 H482096
H480038 H480219 H480408 H480591 H480785 H480999 H481165 H481358 H481582 H481838 H481981 H482039 H482097
H480039 H480222 H480409 H480593 H480786 H481000 H481166 H481359 H481583 H481843 H481982 H482040 H482098
H480043 H480223 H480410 H480610 H480787 H481005 H481168 H481360 H481587 H481846 H481983 H482041 H482099
H480044 H480224 H480422 H480626 H480794 H481006 H481171 H481376 H481601 H481847 H481984 H482042 H482100
H48004S H48022S H48042S H480632 H480795 H481007 H481172 H481414 H481610 H481850 H481985 H482043 H482101
H480051 H480226 H480427 H480633 H480803 H481008 H481176 H481415 H481611 H481851 H481986 H482044 H482102
H480052 H480227 H480428 H480634 H480804 H481009 H481177 H481416 H481612 H481852 H481987 H482045 H482103
H480053 H480228 H480429 H480635 H480808 H481010 H481183 H481417 H481626 H481853 H481988 H482046 H482104
H480054 H480239 H480430 H480636 H480819 H481014 H481188 H481418 H481627 H481854 H481989 H482047 H482105
H4800SS H480240 H480432 H480637 H480820 H481015 H481195 H481423 H481631 H4818SS H481990 H482048 H482106
H480056 H480241 H480448 H480638 H480821 H481016 H481196 H481424 H48163S H481856 H481991 H482049 H482107
H480057 H480242 H480449 H480640 H480826 H481017 H481205 H481429 H481636 H481857 H481992 H482050 H482108
H480058 H480247 H480450 H480641 H480833 H481018 H481206 H481433 H481639 H481877 H481993 H482051 H482109
H480059 H480258 H480451 H480642 H480849 H481019 H481207 H481436 H481644 H481878 H481994 H482052 H482110
H480060 H480259 H480452 H480643 H480850 H481020 H481208 H481437 H481645 H481879 H481995 H482053 H482111
H480061 H480260 H480453 H480644 H480860 H481036 H481211 H481438 H481646 H481884 H481996 H482054 H482112
H480062 H480261 H480454 H480645 H480861 H481039 H481213 H481439 H481667 H481885 H481997 H4820SS H482113
H480078 H480262 H480461 H480651 H480862 H481041 H481218 H481444 H481671 H481886 H481998 H482056 H482120
H480079 H480263 H480464 H480652 H480863 H481044 H481234 H481449 H481672 H481892 H481999 H482057 H482144
H480092 H480264 H48046S H480653 H480871 H481054 H481235 H481450 H481673 H481893 H482000 H482058 H482145
H480093 H480267 H480466 H480654 H480872 H4810SS H481236 H481451 H481674 H481894 H482001 H482059 H482146
H48009S H480268 H480470 H480655 H480875 H481057 H481237 H481452 H481675 H481909 H482002 H482060 H482147
H480096 H480269 H480471 H480657 H480876 H481062 H481239 H481453 H481676 H481916 H482003 H482061 H482164
H480105 H480270 H480473 H480661 H480877 H481065 H481240 H481454 H48168S H481923 H482004 H482062 H482165
H480106 H480271 H480474 H480663 H480878 H481070 H481241 H481460 H481688 H481924 H482005 H482063 H482166
H480107 H480272 H480475 H480676 H480879 H481071 H481249 H481461 H48168
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
650-493-4000
For Additional Information Contact K. Jeffrey Semone
650-424-6833
Manufacturer Reason
for Recall
An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
FDA Determined
Cause 2
Software design
Action Varian Medical Systems will provide all affected consignees with an Urgent Medical Device Correction Letter commencing on November 18, 2013 by federal express. . The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the reported issue.
Quantity in Commerce 6701
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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