Z-0867-2013Class II

Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton...

Name: Z-0867-2013 Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2013-01-28
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2013-01-28 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for... on 2013-01-28. FDA classified it as Class II and gives the reason as "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". 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-0867-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Posted: 2013-02-20
Terminated: 2014-04-04
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: H480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433 , H482765 , H484673 , H486032 , H480106 , H481436 , H482827 , H484677 , H486093 , H480159 , H481437 , H482858 , H484680 , H486094 , H480160 , H481451 , H482859 , H484745 , H486095 , H480247 , H481452 , H482860 , H484746 , H486114 , H480301 , H481453 , H482888 , H484747 , H486140 , H480373 , H481454 , H482889 , H484753 , H486209 , H480374 , H481460 , H482897 , H484830 , H486291 , H480378 , H481461 , H483087 , H484842 , H486369 , H480379 , H481462 , H483204 , H484856 , H486385 , H480408 , H481483 , H483345 , H484950 , H486412 , H480409 , H481532 , H483350 , H484951 , H486442 , H480410 , H481533 , H483351 , H48SOOS , H486473 , H480422 , H481581 , H483352 , H485006 , H486486 , H480471 , H481582 , H483353 , H485090 , H486498 , H480477 , H481601 , H483354 , H485091 , H486499 , H480493 , H481627 , H483406 , H485113 , H486543 , H480566 , H481639 , H483442 , H485127 , H486579 , H4806Sl , H481685 , H483452 , H485143 , H486580 , H480692 , H481766 , H483592 , H485144 , H486615 , H480725 , H481781 , H483617 , H485145 , H486616 , H480764 , H481807 , H483666 , H485162 , H486688 , H480765 , H481815 , H483695 , H485244 , H486689 , H480766 , H481834 , H483696 , H485268 , H486694 , H480794 , H481857 , H483698 , H485308 , H486703 , H480808 , H481879 , H483723 , H485321 , H486716 , H480819 , H481923 , H483724 , H485322 , H486759 , H480820 , H481924 , H483725 , H485359 , H486760 , H480821 , H482166 , H483732 , H485442 , H486858 , H480917 , H482167 , H483733 , H485471 , H486859 , H480918 , H482168 , H483757 , H485481 , H486860 , H481054 , H482181 , H483758 , H485536 , H486861 , H481057 , H482182 , H483759 , H485537 , H486885 , H481112 , H482191 , H483767 , H485541 , H486895 , H481114 , H482192 , H483768 , H485557 , H486896 , H481119 , H482193 , H483840 , H485573 , H486938 , H481120 , H482194 , H483841 , H485580 , H486939 , H481133 , H482243 , H483871 , H485581 , H486941 , H481138 , H482244 , H483872 , H485582 , H486957 , H481154 , H482246 , H483943 , H485592 , H487011 , H481155 , H482266 , H483967 , H485595 , H487012 , H481164 , H482267 , H483968 , H485628 , H487277 , H481165 , H482323 , H483969 , H485689 , H487278 , H481166 , H482367 , H483993 , H485694 , H487279 , H481168 , H482385 , H484008 , H485706 , H487302 , H481171 , H482386 , H484023 , H485729 , H487428 , H481172 , H482387 , H484056 , H485776 , H487512 , H481196 , H482388 , H484153 , H485777 , H487513 , H481206 , H482391 , H484154 , H485792 , H487580 , H481207 , H482579 , H484168 , H485800 , H487621 , H481208 , H482580 , H484169 , H485890 , H487639 , H481211 , H482581 , H484274 , H485891 , H487698 , H481218 , H482638 , H484367 , H485892 , H487700 , H487771 , H48A323 , H48B875 , H48C805 , H487772 , H48A398 , H48B887 , H48C806 , H487775 , H48A462 , H48B898 , H48C807 , H487778 , H48A474 , H488899 , H48C808 , H487895 , H48A482 , H48B900 , H48C809 , H487950 , H48AS12 , H48C084 , H48C854 , H487980 , H48AS13 , H48C085 , H48C8SS , H487999 , H48ASSS , H48C086 , H48C866 , H488005 , H48AS87 , H48C116 , H48C881 , H488029 , H48AS90 , H48C120 , H4800Sl , H4880SS , H48AS91 , H48C121 , H480113 , H488102 , H48AS92 , H48C134 , H480118 , H488163 , H48AS93 , H48C135 , H480171 , H488210 , H48AS94 , H48C136 , H48D177 , H488211 , H48AS95 , H48C137 , H48D179 , H488229 , H48A612 , H48C138 , H48D187 , H488237 , H48A614 , H48C173 , H48D211 , H488238 , H48A713 , H48C174 , H48D235 , H488243 , H48A760 , H48C176 , H48D315 , H488249 , H48A762 , H48C212 , H48D316 , H488291 , H48A816 , H48C252 , H48D317 , H488311 , H48A818 , H48C253 , H48D318 , H488312 , H48A890 , H48C278 , H480319 , H488483 , H48A918 , H48C316 , H480320 , H489074 , H48A920 , H48C356 , H480321 , H489079 , H48A956 , H48C367 , H480347 , H489095 , H48A971 , H48C373 , H480349 , H489096 , H48A986 , H48C399 , H480353 , H489114 , H48A987 , H48C434 , H480354 , H489379 , 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 , H48A712 , H481836 , H48F479 , H48F443 , H483856 , H48F733 , H48G587 , H48C096 , H48E762 , H48F345 , H487982 , H487782 , H48E427 , H480535 , H48B845 , H480323 , H48F444 , H48G405 , H48C540 , H48G588 , H48C097 , H48E763 , H483697 , H48B252 , H487798 , H48E441 , H484052 , H48F053 , H480324 , H481289 , H481828 , H48C541 , H48G589 , H48C098 , H48E764 , H48F765 , H48F338 , H48G414 , H48E514 , H48F615 , H480971 , H480325 , H481290 , H481829 , H484381 , H48G590 , H48C099 , H48F240 , H487773 , H48F352 , H481315 , H48E517 , H48F617 , H485963 , H486683 , H481291 , H481830 , H488320 , H48G591 , H48C100 , H48F241 , H48G267 , H48F353 , H481316 , H489872 , H48F724 , H482203 , H480262 , H481292 , H481831 , H487595 , H48G592 , H48C101 , H48F326 , H48F355 , H488452 , H481334 , H48F727 , H486934 , H48A254 , H481293 , H480873 , H48F833 , H48GS93 , H48C102 , H48F327 , H482935 , H48A911 , H481335 , H48F729 , H48B366 , H48G584 , H482201 , H480874 , H48F834 , H485100 , H48C103 , H483509 , H485125 , H48C104 , H482381 , H484280 , H480346 , H48A295 , H48B057 , H48G002 , H48E984 , H48F483 , H482383 , H48F942 , H487212 , H48C105 , H486701 , H482164 , H481510 , H48A296 , H48E537 , H48G004 , H48E985 , H48F484 , H483649 , H485896 , H480107 , H48F754 , H48E973 , H486370 , H482289 , H48A184 , H482196 , H48G006 , H48E986 , H483374 , H480830 , H481063 , H480920 , H48F755 , H48E974 , H483506 , H482807 , H480556 , H484018 , H48G007 , H48E987 , H483375 , H483615 , H48A395 , H482793 , H48F756 , H48E975 , H485400 , H487623 , H480557 , H484019 , H484624 , H48E988 , H483376 , H485821 , H48G198 , H480051 , H48F757 , H48E976 , H48B549 , H48E962 , H480558 , H484020 , H480933 , H48F790 , H487866 , H480004 , H481077 , H480052 , H48F758 , H486927 , H483964 , H48E977 , H486581 , H48F526 , H480934 , H48F186 , H487867 , H48F428 , H481078 , H480053 , H484497 , H480692 , H484903 , H48E978 , H48F054 , H480348 , H48F868 , H480530 , H488820 , H48F595 , H482263 , H480054 , H484498 , H480693 , H486069 , H48E979 , H48F059 , H480349 , H481837 , H480055 , H484499 , H488056 , H486071 , H48E980 , H487776 , H482382 , H481838

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0867-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0867-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code MUJ

K102011Class IIEclipse Treatment Planning SystemVarian Medical Systems, Inc. / cleared 2010-09-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)