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U.S. Department of Health and Human Services

Class 2 Device Recall Varian

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  Class 2 Device Recall Varian see related information
Date Initiated by Firm March 26, 2013
Date Posting Updated April 23, 2013
Recall Status1 Terminated 3 on July 09, 2014
Recall Number Z-1163-2013
Recall Event ID 64828
510(K)Number K102024  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2

Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Code Information HS02984 H503113 HS03228 H503320 HS03407 HS03511 HS03598 H503693 H503790 H503890 HS03982 H504060, H502765 H502985 H503114 H503229 HS03321 H503408 H503512 H503599 H503696 HS03792 H503893 HS03984 H504061, H502769 H502986 H503118 H503230 HS03322 H503409 H503513 HS03601 H503697 H503793 H503894 H503985 H504062, H502772 H502988 HS03119 H503231 HS03323 H503410 H503SIS H503602 H503698 H503794 H503895 H503986 H504063, H502774 H502989 HS03121 H503232 HS03324 H503411 H503516 HS03603 HS03700 H503798 H503897 H503987 H504064, H502775 HS02991 H503122 H503233 HS03325 HS03412 H503517 H503605 HS03704 H503799 H503898 H503988 H504066, HS02778 H502992 H503123 H503234 HS03326 HS03414 H503518 H503606 H503706 H503800 H503900 H503989 H504067, H502780 H502995 H503127 H503235 H503328 HS03418 HS03519 H503607 H503707 H503801 HS03902 HS03990 H504069, H502783 HS02996 H503128 H503239 H503330 HS03419 H503520 H503608 H503708 H503802 H503903 H503991 H504070, HS02784 HS02997 H503131 HS03240 H503331 H503420 H503522 H503609 H503709 H503803 HS03910 H503992 H504071, H502789 H502998 H503136 H503241 HS03333 HS03425 H503523 H503610 H503712 H503804 H503913 H503994 H504072, H502790 H503004 H503137 HS03242 H503335 H503426 H503527 H503611 H503713 H50380S H503914 H503996 HS04073, H502792 H503006 H503138 H503243 HS03336 H503427 H503528 HS03615 H503714 H503806 HS03915 H503999 H504074, H502796 HS03007 H503139 H503244 H503337 HS03428 H503530 H503616 H503716 H503807 H503917 H504000 H504075, H502801 H503008 H503140 H503246 H503339 H503430 H503531 H503617 HS03717 H503808 H503918 H504001 H504076, H502803 H503009 HS03142 H503247 H503340 H503431 H503534 H503618 H503719 HS03809 H503919 H504002 H504077, H502809 H503013 H503143 H503249 H503341 H503432 H503535 H503619 HS03720 HS03810 H503920 HS04004 HS04080, H502811 H503014 H503144 H503250 H503342 H503433 H503536 H503620 H503723 HS03821 H503921 H504005 H504085, HS02812 H503023 H503145 H503254 H503343 H503434 H503537 H503621 HS03724 HS03822 HS03922 H504008 HS04086, H502816 H503024 H503148 H5032SS H503345 H503436 H503538 H503624 H503726 H503825 H503923 HS04009 H504087, H502818 H503027 H503149 H503256 H503346 H503442 H503539 H503625 H503729 HS03826 H503924 H504010 H504088, H502819 H503033 H503150 HS03259 H503347 HS03444 H503541 HS03626 H503730 H503829 HS03925 H504011 H504089, H502826 HS03034 HS03151 HS03262 HS03348 HS0344S H503543 HS03627 HS03731 HS03831 H503928 HS04012 HS04090, H502832 H503036 HS03153 HS03263 HS03349 H503446 H503547 H503629 HS03733 H503834 HS03929 HS04014 H504091, HS02868 H503037 H503156 H503266 H503351 HS03449 H503548 H503630 H503734 H503836 H503930 H504015 H504092, H502874 H503039 HS03158 HS03267 H503352 H503450 H503549 HS03632 H503736 H503839 HS03934 H504016 H504093, H502876 H503041 H503159 H503269 H503355 H503451 HS03SSO H503633 H503737 H503840 H503935 H504017 H504094, H502877 H503042 H503160 H503270 H503356 H503453 H503551 H503635 HS03738 H503842 H503937 H504018 HS0409S H502881 HS03043 HS03162 H503271 H503357 H503454 HS03552 HS03636 HS03739 HS03844 HS03938 HS04020 HS04096, H502884 H503047 H503167 HS03274 HS03359 H503457 H503553 H503637 H503741 H503845 H503939 H504022 H504098, H502886 H503049 HS03168 H503275 H503360 H503458 H503554 H503640 H503742 H503846 HS03940 H504023 H504099, H502888 HS03050 H503169 HS03276 HS03361 H503460 H503555 HS03641 H503743 H503847 H503941 H504024 H504100, H502889 H503051 H503170 H503277 H503362 H503463 H503556 H503642 H503745 H503848 H503942 H504025 HS04101, HS02892 HS03053 HS03173 HS03279 HS03363 H503464 HS03557 HS03643 HS03747 H503850 H503943 H504026 H504102, H502896 H503054 HS03174 HS03280 H503364 H503466 H503558 HS03644 HS03750 H503851 H503944 HS04028 HS04103, H502897 H503056 HS03175 H503281 H503366 H503469 H503559 HS03645 HS037Sl H503852 HS03946 H504029 H504104,

H502901 H503057 H503176 H503282 H503367 H503470 H503560 H503646 H503752 H503858 H503949 H504031 HS04106, HS02905 H503060 H503177 H503283 HS03368 HS03471 HS03561 HS03647 H503754 HS03860 HS039SO H504032 HS04107, HS02907 HS0306
Recalling Firm/
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Patricia A. Erwin
Manufacturer Reason
for Recall
Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
FDA Determined
Cause 2
Device Design
Action Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice Letter dated March 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain a copy of this document along with their most current product labeling, advise the appropriate personnel of the content of this letter, and for future reference this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. The letter stated that a Varian Medical Systems has developed a technical correction and a Customer Service representative will contact customers to schedule installation. For question contact your local Varian medical Systems Customer Support District or Regional Manager.
Quantity in Commerce 2508 units
Distribution Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.
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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS