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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 Posted April 23, 2013
Recall Status1 Terminated 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 HS00213 H500538 HS00727 HS00968 H501175 H501386 HS01600 HS01780 H501977 HS02163 HS02341 HS02488 H502655
H50025l H500539 HS00728 HS00973 H501178 H501387 HS01603 H501782 H501979 H502164 H502342 H502489 H502656
HS00254 HSOOS45 HS00729 HS00978 H501190 H501390 H501605 H501784 H501982 H502166 HS02344 H502495 H502661
H50026l H500548 H500730 H50098l H501193 H501392 H501606 H501790 H501983 H502168 H502345 HS02502 HS02662
H500262 H500549 H500735 HS00986 H50ll94 HS01393 HSOI608 HS01792 HS01986 H502170 H502346 H502504 HS02664
HS00271 HSOOSSO HS00736 HS00991 HS01198 HS01396 H501610 H501797 HS01988 HS02171 HS02347 HS02SOS HS02666
HS00283 HS00551 HS00749 HSOI002 H501202 H501403 H501612 H501800 H501990 H502172 HS02348 H502506 H502672
HS00286 HSOOSS7 HS007Sl HSOIOOS HS01203 HSOI410 H501616 HS01804 H501992 H502173 HS02350 H502509 HS02673
HS00287 H500561 HS00753 HS01009 HS01210 HSOI417 HS01617 H5018ll H501995 H502174 H502352 H502510 HS02674
HS00288 H500563 HS00754 HSOIOII HS01224 HS01418 HSOI622 H501815 HS02000 HS02176 HS02355 HS02513 HS02677
HS00289 HS00567 H500758 HS01012 HS01228 HS01420 H501624 HSOI819 HS02001 H502191 HS02356 HS02516 HS02680

H500294 H500573 H500759 HSOIOIS HSOI232 HSOI424 H501625 H501823 H502002 H502193 H502359 H502518 H502681
HS00303 H500574 H500762 HSOI020 HSOI233 HSOI432 HSOI631 H501824 HS02006 HS02196 H502360 H502521 H502682
H500309 H500576 H500764 HSOI034 HSOI235 HSOI434 H501633 H501832 HS02012 HS02198 H502362 H502524 HS02683
H500317 H500577 H500768 H501038 H501236 H501435 H501639 H501837 H502013 H502200 H502363 H502529 HS02684
H500321 H500579 H500775 H501040 H501240 HS01437 H501640 H501838 H502015 H502201 HS02364 H502531 H502687
H500324 H500584 HS00782 HSOI041 HSOI241 HS01439 H501646 HS01850 HS02017 H502204 H502366 HS02532 HS02688
HS00337 H500604 HS00784 HSOI044 HSOI247 HS01445 H501651 H501853 HS02018 HS02207 H502367 HS02533 HS02689
HS00340 H500605 H500787 HSOIOS6 HS01254 H501448 H501654 H501854 HS02020 HS02210 H502368 HS02536 HS02690
HS0036S HS00610 HS00796 HSOIOS8 HSOI2SS HS01449 HS01657 HS01858 HS02022 HS02214 H502369 HS02537 H50269S HS02698 HS02929 HS03074 HS03189 HS03295 H503375 HS03482 HS03571 HS03661 HS03761 HS03868 H503959 H504040
HS02703 HS02934 HS03076 HS03190 H503297 H503377 HS03483 H503572 HS03663 H503762 H503869 HS03960 H504041
HS02706 HS02936 HS03077 HS03191 HS03299 HS03378 H503486 H503573 HS03667 HS03763 H503871 HS03961 H504042
HS02707 H502937 H503078 HS03192 HS03301 HS03380 H503488 H503574 HS03668 H503764 H503872 H503963 H504043
HS02709 H502938 HS03079 HS03193 HS03302 HS03381 HS03489 HS03576 HS03669 HS03765 HS03873 H503964 HS04044
HS02715 H502943 HS03084 HS03194 H503303 HS03382 HS03492 H503577 H503670 H503766 H503874 H503965 HS04045
HS02716 H502951 H503085 H503195 H503305 H503384 H503493 H503581 H503672 HS03767 H503875 H503966 H504046
H502717 H502953 H503089 H503196 H503306 H503387 H503496 H503582 H503674 H503773 HS03876 H503967 H504047
H502718 H502956 H503090 H503203 HS03307 H503388 H503497 H503584 H503675 H503774 HS03877 H503968 H504048
H502722 H502960 H503092 H503209 H503308 H503389 H503500 H503585 H503676 H503775 H503879 HS03969 H504050
H502732 H502965 H503093 H503210 H503310 H503390 HS03501 HS03588 HS03677 H503777 H503881 HS03970 HS040Sl
HS02733 HS02967 H503098 H503213 H503311 HS03391 H503503 HS03590 HS03678 HS03778 H503882 HS03971 HS04052
H502734 H502971 H503099 HS03214 HS03313 HS03392 HS03504 HS03592 H503679 HS03779 HS03883 HS03972 HS04053
H502739 HS02972 HS03100 HS03216 HS03314 HS03393 H503505 HS03593 HS03680 HS03780 HS03884 HS03974 H504054
HS02745 HS02975 HS03101 H503220 HS03315 HS03397 HS03506 HS03594 HS03682 HS03781 H503886 HS03977 HS040SS
HS02749 HS02978 H503102 HS03224 H503316 H503398 H503507 HS03595 HS03683 HS03782 HS03887 HS03978 H504056
HS02750 HS02980 H503111 H503226 HS03318 HS03404 HS03508 HS03596 HS03684 HS03783 H503888 HS03979 HS04057
H502752 HS02982 HS03112 HS03227 HS03319 HS03406 H503509 HS03597 H503689 HS03786 H503889 HS03980 H504058
HS02763
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
650-424-5731
For Additional Information Contact Patricia A. Erwin
650-424-5731
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS
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