Recall of Device Recall 52leaf Millennium MLC multileaf collimator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61074
  • Event Risk Class
    Class 2
  • Event Number
    Z-1091-2012
  • Event Initiated Date
    2012-01-16
  • Event Date Posted
    2012-02-23
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-07-26
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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.
  • 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.

Device

  • Model / Serial
    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 Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    Varian brand 52-leaf Millennium MLC multileaf collimator; || Reference/FSCA Identifier: CP-04792; 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
  • Source
    USFDA