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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 Initiated by Firm January 28, 2013
Date Posting Updated February 20, 2013
Recall Status1 Terminated 3 on April 04, 2014
Recall Number Z-0867-2013
Recall Event ID 64319
510(K)Number K102011  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Code Information 9 , H48B109 , H48C441 , H48D356

H489417 , H48B138 , H48C442 , H48D394

H489431 , H488216 , H48C443 , H48D397

H489432 , H48B2S9 , H48C448 , H48DS17

H489433 , H48B293 , H48C450 , H48DS24

H489792 , H48B294 , H48C474 , H48D654

H489793 , H48B295 , H48C475 , H48D688

H489794 , H48B331 , H48C476 , H48D689

H489819 , H48B332 , H48CSS7 , H48D690

H489953 , H488333 , H48CSS8 , H480758

H489996 , H48B334 , H48CSS9 , H48D956

H48A029 , H48B399 , H48CS60 , H480957

H48A083 , H48B471 , H48CS61 , H48D988

H48A084 , H48B472 , H48CS75 , H48D992

H48A085 , H48B480 , H48CS76 , H480993

H48Al47 , H48BS86 , H48C661 , H48E031

H48A148 , H48BS87 , H48C688 , H48E069

H48A149 , H488588 , H48C689 , H48E106

H48A150 , H48BS89 , H48C715 , H48El39

H48A202 , H48B602 , H48C717 , H48E143

H48A224 , H488605 , H48C795 , H48El52

H48A225 , H488691 , H48C796 , H48El53

H48A226 , H48B692 , H48C797 , H48E154

H48A229 , H48B693 , H48C798 , H48El59

H48A230 , H48B694 , H48C799 , H48E422

H48A243 , H488787 , H48C800 , H48E423

H48ES68 , H48F073 , H48FS17 , H48F927

H48ES90 , H48F074 , H48FS18 , H48F939

H48ES91 , H48F075 , H48FS19 , H48F944

H48ES92 , H48F076 , H48FS23 , H48F948

H48ES93 , H48F077 , H48FS24 , H48F980

H48ES95 , H48F078 , H48FS34 , H48F993

H48E609 , H48F079 , H48FS36 , H48F994

H4BE677 , H48F083 , H4BF537 , H48G020

H48EB16 , H48F084 , H48FS44 , H48G021

H48E883 , H4BF085 , H48FS45 , H48G039

H48E884 , H48F086 , H48FS46 , H48G041

H48E885 , H48F089 , H48FS47 , H48G109

H48E888 , H48F120 , H48FS48 , H48Gll7

H48E890 , H48F131 , H48FS49 , H48G123

H48E892 , H48F132 , H48FSSO , H48G153

H48E893 , H48F134 , H48F568 , H48G154

H48E894 , H48F135 , H48FS92 , H48Gl84

H48E908 , H48F136 , H48F606 , H48G185

H48E909 , H48F137 , H48F609 , H48G228

H48E913 , H48F138 , H48F623 , H48G229

H48E914 , H4BF156 , H48F624 , H48G230

H48E915 , H48F166 , H48F637 , H48G235

H48E916 , H48F167 , H4BF647 , H4BG236

H4BE917 , H4BF168 , H4BF648 , H48G238

H4BE918 , H4BF169 , H48F649 , H48G241

H48E919 , H4BF170 , H48F697 , H48G242

H48E920 , H48F184 , H48F698 , H48G246

H48E921 , H48F185 , H48F713 , H48G247

H4BE922 , H48F194 , H48F714 , H4BG249

H4BE932 , H48F195 , H48F715 , H4BG250

H4BE933 , H48F196 , H48F760 , H48G275

H48E944 , H4BF197 , H48F761 , H48G276

H48E945 , H48F199 , H48F777 , H48G277

H4BE946 , H48F219 , H48F779 , H48G278

H48E947 , H4BF268 , H48F780 , H48G279

H48E948 , H48F312 , H48F791 , H4BG280

H48E952 , H48F315 , H48F792 , H48G281

H48E954 , H48F316 , H48F796 , H48G282

H48E957 , H48F317 , H4BF824 , H48G283

H4BE964 , H48F318 , H48FB25 , H48G284

H48E966 , H4BF331 , H48F826 , H48G285

H4BE989 , H4BF332 , H48F827 , H48G286

H48E990 , H48F333 , H48F828 , H48G289

H48E991 , H4BF354 , H48F829 , H48G290

H48E992 , H48F394 , H48F835 , H4BG291

H48E994 , H48F395 , H48F836 , H48G292

H48E996 , H48F399 , H48F837 , H48G293

H48F002 , H48F400 , H48F843 , H48G294

H48F013 , H48F426 , H48F844 , H48G295

H48F014 , H48F468 , H48FB45 , H48G296

H48F016 , H48F469 , H48F852 , H48G363

H4BF017 , H48F470 , H48F854 , H48G405

H4BF018 , H48F490 , H48FBS6 , H48G413

H48F025 , H48FS06 , H48F859 , H48G414

H48F028 , H48FS07 , H48F865 , H48G487

, H481328 , H482681 , H484368 , H485893 , H487736 , H48A244 , H48B816 , H48C801 , H48E425 , H48F029 , H48FS08 , H48F922 , H483654

H481329 , H482682 , H484435 , H485894 , H487737 , H48A245 , H48B818 , H48C802 , H48ES66 , H48FOS8 , H48FS09 , H48F925 , H48F393

H481352 , H482732 , H484495 , H485895 , H487739 , H48A246 , H48B819 , H48C803 , H48ES67 , H48F072 , H48F516 , H48F926 , H482411

H480974 , H48G246 , H480803 , H48B712 , H487089 , H482936 , H48A812 , H487040 , H48F730 , H48G585 , H486116 , H480875 , H482412

H482384 , H48G247 , H481184 , H480536 , H481835 , H48F478 , H48F246 , H481005 , H48F731 , H48G586 , H48C095 , H480876 , H484904

H487981 , H487466 , H48E426
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Patricia A. Erwin
650-424-5731
Manufacturer Reason
for Recall
The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
FDA Determined
Cause 2
Software design
Action Varian Medical Systems, Inc. Oncology Systems sent an Urgent Medical Device Correction Letter dated January 30, 2013 to all affected customers. The Letter identified the affected product, problem and actions to be taken. Varian Medical Systems is developing a technical correction for this issue, Its customers will be contacted by a Varian Customer Service representatives when this correction is available to schedule its installation. The letter provides customers with help desk contact information.
Quantity in Commerce 1168 units
Distribution Worldwide Distribution - USA Nationwide
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 = MUJ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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