Z-1090-2012

Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model...

Name: Z-1090-2012 Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2012-01-16
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-01-16 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM... on 2012-01-16. The reason FDA records is "When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1090-2012
Status: Terminated
Initiated: 2012-01-16
Posted: 2012-02-23
Terminated: 2012-07-26
Recalling firm: Varian Medical Systems, Inc.
Product: Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.
Root cause tag: design
FDA root cause: Device Design
Action: Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides recommended actions when planning and treating dynamic fields on the 52 leaf MLCs. Contact the Help Desk at 1-888-827-4265 for questions regarding this recall.
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Canada, China, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Singapore, Bahrain, Egypt, Hong Kong, India, Indonesia, Israel, Malaysia, Morocco, Nepal, South Africa, South Korea, Taiwan, Turkey, Ukraine, United Arab Emirates, Japan, Brazil, Chile, Colombia, Mexico, Panama, Venezuela, Saudi Arabia, and Australia.
Product codes and lots: Serial Numbers/CODES: H520102 ,H520235 ,H520362 ,H520458 ,H520542 ,H520614 ,H520682 ,H520740 ,H520797 ,H520116 ,H520237 ,H520364 ,H520461 ,H520545 ,H520615 ,H520684 ,H520743 ,H520798 ,H520122 ,H520244 ,H520367 ,H520468 ,H520546 ,H520618 ,H520685 ,H520745 ,H520799 ,H520126 ,H520247 ,H520368 ,H520474 ,H520547 ,H520619 ,H520687 ,H520746 ,H520800 ,H520130 ,H520251 ,H520369 ,H520481 ,H520548 ,H520620 ,H520689 ,H520747 ,H520801 ,H520134 ,H520300 ,H520370 ,H520482 ,H520552 ,H520622 ,H520690 ,H520748 ,H520804 ,H520136 ,H520302 ,H520373 ,H520485 ,H520553 ,H520624 ,H520691 ,H520750 ,H520808 ,H520138 ,H520304 ,H520378 ,H520488 ,H520554 ,H520625 ,H520693 ,H520752 ,H520809 ,H520141 ,H520305 ,H520380 ,H520489 ,H520555 ,H520626 ,H520695 ,H520755 ,H520810 ,H520146 ,H520311 ,H520381 ,H520490 ,H520557 ,H520627 ,H520697 ,H520756 ,H520811 ,H520154 ,H520312 ,H520386 ,H520493 ,H520559 ,H520628 ,H520698 ,H520757 ,H520813 ,H520156 ,H520315 ,H520387 ,H520496 ,H520560 ,H520630 ,H520699 ,H520760 ,H520815 ,H520161 ,H520318 ,H520391 ,H520499 ,H520563 ,H520631 ,H520700 ,H520761 ,H520817 ,H520168 ,H520319 ,H520394 ,H520501 ,H520564 ,H520632 ,H520701 ,H520762 ,H520818 ,H520169 ,H520320 ,H520395 ,H520505 ,H520566 ,H520633 ,H520704 ,H520763 ,H520820 ,H520172 ,H520322 ,H520396 ,H520506 ,H520571 ,H520637 ,H520707 ,H520765 ,H520821 ,H520175 ,H520324 ,H520398 ,H520508 ,H520575 ,H520639 ,H520708 ,H520766 ,H520823 ,H520179 ,H520326 ,H520406 ,H520509 ,H520577 ,H520640 ,H520710 ,H520767 ,H520824 ,H520180 ,H520328 ,H520408 ,H520511 ,H520578 ,H520642 ,H520714 ,H520768 ,H520827 ,H520182 ,H520329 ,H520409 ,H520512 ,H520580 ,H520643 ,H520715 ,H520769 ,H520828 ,H520183 ,H520330 ,H520410 ,H520513 ,H520582 ,H520647 ,H520717 ,H520771 ,H520832 ,H520184 ,H520333 ,H520412 ,H520514 ,H520584 ,H520648 ,H520718 ,H520772 ,H520833 ,H520186 ,H520334 ,H520413 ,H520517 ,H520585 ,H520649 ,H520719 ,H520773 ,H520840 ,H520190 ,H520335 ,H520414 ,H520518 ,H520587 ,H520650 ,H520720 ,H520774 ,H520841 ,H520191 ,H520336 ,H520421 ,H520520 ,H520589 ,H520654 ,H520721 ,H520775 ,H520843 ,H520192 ,H520338 ,H520423 ,H520521 ,H520590 ,H520659 ,H520722 ,H520776 ,H520849 ,H520197 ,H520340 ,H520432 ,H520522 ,H520596 ,H520660 ,H520724 ,H520778 ,H520851 ,H520198 ,H520346 ,H520436 ,H520524 ,H520598 ,H520661 ,H520726 ,H520783 ,H520852 ,H520199 ,H520347 ,H520437 ,H520525 ,H520599 ,H520663 ,H520727 ,H520784 ,H520853 ,H520202 ,H520350 ,H520438 ,H520529 ,H520600 ,H520664 ,H520728 ,H520785 ,H520854 ,H520204 ,H520351 ,H520439 ,H520531 ,H520601 ,H520665 ,H520731 ,H520786 ,H520855 ,H520205 ,H520352 ,H520440 ,H520532 ,H520605 ,H520666 ,H520732 ,H520790 ,H520856 ,H520211 ,H520354 ,H520442 ,H520533 ,H520609 ,H520671 ,H520734 ,H520793 ,H520857 ,H520216 ,H520356 ,H520443 ,H520535 ,H520610 ,H520674 ,H520737 ,H520794 ,H520858 ,H520217 ,H520357 ,H520445 ,H520537 ,H520611 ,H520678 ,H520738 ,H520795 ,H520859 ,H520221 ,H520359 ,H520447 ,H520541 ,H520612 ,H520679 ,H520739 ,H520796 ,H520860 ,H541142 ,H561022 ,H561064 ,H561137 ,H561176 ,HHM0006 ,HHM0064 ,H541227 ,H561023 ,H561067 ,H561138 ,H561178 ,HHM0007 ,HHM0066 ,H541249 ,H561024 ,H561069 ,H561139 ,H561179 ,HHM0008 ,HHM0067 ,H541331 ,H561025 ,H561070 ,H561140 ,H561180 ,HHM0009 ,HHM0069 ,H541344 ,H561026 ,H561076 ,H561141 ,H561181 ,HHM0010 ,HHM0099 ,H541425 ,H561027 ,H561096 ,H561142 ,H561182 ,HHM0011 ,HHM1202 ,H541429 ,H561028 ,H561100 ,H561144 ,H561185 ,HHM0012 ,H541449 ,H561029 ,H561101 ,H561145 ,H561186 ,HHM0013 ,H541463 ,H561030 ,H561102 ,H561146 ,H561187 ,HHM0014 ,H541465 ,H561031 ,H561103 ,H561147 ,H561188 ,HHM0015 ,H541467 ,H561033 ,H561104 ,H561148 ,H561189 ,HHM0016 ,H541640 ,H561034 ,H561105 ,H561149 ,H561190 ,HHM0017 ,H542515 ,H561035 ,H561106 ,H561150 ,H561191 ,HHM0018 ,H542737 ,H561036 ,H561107 ,H561151 ,H561192 ,HHM0019 ,H542755 ,H561037 ,H561109 ,H561152 ,H561193 ,HHM0020 ,H542834 ,H561038 ,H561110 ,H561153 ,H561194 ,HHM0022 ,H543057 ,H561039 ,H561111 ,H561154 ,H561195 ,HHM0023 ,H543093 ,H561040 ,H561112 ,H561155 ,H561196 ,HHM0024 ,H543311 ,H561041 ,H561113 ,H561156 ,H561199 ,HHM0025 ,H544189 ,H561043 ,H561114 ,H561157 ,H561200 ,HHM0026 ,H545563 ,H561044 ,H561115 ,H561158 ,H561201 ,HHM0027 ,H545773 ,H561045 ,H561116 ,H561159 ,H561203 ,HHM0028 ,H561006 ,H561046 ,H561117 ,H561160 ,H561204 ,HHM0029 ,H561008 ,H561047 ,H561118 ,H561161 ,H561205 ,HHM0030 ,H561009 ,H561048 ,H561119 ,H561162 ,H561206 ,HHM0031 ,H561010 ,H561050 ,H561120 ,H561163 ,H561207 ,HHM0032 ,H561011 ,H561052 ,H561121 ,H561166 ,H561208 ,HHM0033 ,H561012 ,H561053 ,H561122 ,H561167 ,H561209 ,HHM0034 ,H561013 ,H561054 ,H561123 ,H561168 ,H561210 ,HHM0035 ,H561015 ,H561057 ,H561124 ,H561169 ,H561211 ,HHM0036 ,H561016 ,H561058 ,H561126 ,H561170 ,H561212 ,HHM0038 ,H561017 ,H561059 ,H561128 ,H561171 ,H561215 ,HHM0039 ,H561018 ,H561060 ,H561130 ,H561172 ,H563989 ,HHM0060 ,H561019 ,H561061 ,H561134 ,H561173 ,H564795 ,HHM0061 ,H561020 ,H561062 ,H561135 ,H561174 ,HHM0004 ,HHM0062 ,H561021 ,H561063 ,H561136 ,H561175 ,HHM0005 ,HHM0063

Product code IYE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)