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U.S. Department of Health and Human Services

Class 2 Device Recall IGuide System

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  Class 2 Device Recall IGuide System see related information
Date Initiated by Firm July 18, 2019
Create Date July 25, 2019
Recall Status1 Terminated 3 on August 11, 2023
Recall Number Z-2082-2019
Recall Event ID 83358
510(K)Number K072079  
Product Classification Accelerator, linear, medical - Product Code IYE
Product IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2

Product Usage:

Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Code Information UDI (GTIN) iGuide 2.2.0 = 04056719001704 iGuide 2.2.1 = 04056719001742  iGuide 2.2.2 = 04056719002039  Installed on the following units: Master Devices with serial numbers: VERSA HD/30002624-003/154166 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 ELEKTA INFINITY/19175-003/154363 VERSA HD/30001056-002/109016 VERSA HD/30001009-001/153427 ELEKTA INFINITY/11766-003/152570 VERSA HD/11766-004/153649 ELEKTA SYNERGY/11766-002/151717 VERSA HD/17114-001/153383 VERSA HD/19677-005/109018 VERSA HD/30003910-LIN001/109005 VERSA HD/30003903-LIN001/109006 VERSA HD/30003903-LIN002/109035 VERSA HD/30001230-003/153428 VERSA HD/15081-LIN003/109003 ELEKTA SYNERGY/15081-002/152131 VERSA HD/12486-003/109036 VERSA HD/15240-003/109033 ELEKTA SYNERGY/15240-001/152128 ELEKTA SYNERGY/15240-002/152419 ELEKTA SYNERGY/20967-001/153012 VERSA HD/30003249-001/154299 VERSA HD/14756-002/153003 ELEKTA SYNERGY/14756-001/151916 ELEKTA SYNERGY/12579-003/152379 ELEKTA AXESSE/18225-001/152691 VERSA HD/18225-003/153900 VERSA HD/30001349-001/154087 VERSA HD/20965-001/153008 VERSA HD/30002428-LIN001/154024 ELEKTA AXESSE/11654-003/152617 VERSA HD/11654-006/109013 VERSA HD/10394-AKHEE/153248 VERSA HD/12570-#001/154395 VERSA HD/12570-#002/154435 VERSA HD/12490-KLG02E/154043 VERSA HD/12490-KLG04/153699 VERSA HD/17152-#001/156066 ELEKTA SYNERGY/10266-IBK02E/152807 VERSA HD/10266-IBK05/153055 VERSA HD/10266-IBK01E/154680 ELEKTA SYNERGY/10266-IBK04/151431 VERSA HD/11517-C8230/154221 VERSA HD/11517-C8220/154473 ELEKTA SYNERGY/11517-C8210/151888 ELEKTA SYNERGY/11517-C8200/151483 VERSA HD/10587-001/154730 VERSA HD/16805-002/153976 VERSA HD/30003118-002/154744 VERSA HD/30003118-001/154743 VERSA HD/30003118-003/154745 VERSA HD/30003118-004/154746 ELEKTA INFINITY/14770-003/153005 iGUIDE Software/14770-001/2.2.2 ELEKTA INFINITY/12473-012/152957 ELEKTA INFINITY/12473-013/152956 ELEKTA INFINITY/15012-008/152853 ELEKTA INFINITY/15012-007/153015 ELEKTA INFINITY/13219-004/153852 ELEKTA INFINITY/12274-021/153049 ELEKTA INFINITY/14771-001/152692 ELEKTA INFINITY/14771-002/152979 VERSA HD/20491-001/154325 ELEKTA INFINITY/12678-003/154786 VERSA HD/20531-001/154705 ELEKTA INFINITY/15291-002/154761 ELEKTA INFINITY/12709-002/154790 VERSA HD/30003232-001/154528 iGUIDE Software/30003232-001/2.2.2 ELEKTA INFINITY/30004215-001/154734 VERSA HD/30002674-003/154149 ELEKTA INFINITY/13128-002/154630 ELEKTA INFINITY/20612-001/154775 VERSA HD/19096-001/154701 VERSA HD/30003818-001/154760 ELEKTA AXESSE/30001262-001/154969 ELEKTA INFINITY/12659-003/154894 ELEKTA INFINITY/21118-002/154423 ELEKTA INFINITY/13431-008/154806 ELEKTA INFINITY/17556-002/154977 VERSA HD/12634-003/154900 ELEKTA INFINITY/30000925-002/154619 ELEKTA INFINITY/30003865-001/154605 VERSA HD/19919-002/154421 ELEKTA INFINITY/17128-004/154475 VERSA HD/12668-005/154551 VERSA HD/12668-005/154551 ELEKTA INFINITY/19137-002/154699 ELEKTA SYNERGY/13123-002/154715 VERSA HD/30003134-L14501/154398 ELEKTA SYNERGY/13166-ZLI002/154005 ELEKTA SYNERGY/10562-008/151787 ELEKTA SYNERGY/10562-004/151666 VERSA HD/10562-009/152843 VERSA HD/10562-010/152912 VERSA HD/10419-007/154808 VERSA HD/30003123-001/154324 VERSA HD/10102-001/154723 VERSA HD/12500-004/154198 VERSA HD/12510-003/153876 IGUIDE¿ 2.2.2 FCO MOD KIT/12523-003/2.2.2 VERSA HD/12525-008/154077 VERSA HD/12525-009/154981 ELEKTA SYNERGY/14785-001/152376 VERSA HD/12508-003/154550 VERSA HD/11666-004/153104 VERSA HD/15250-002/153872 VERSA HD/11868-012/156052 VERSA HD/12538-003/153836 VERSA HD/18578-001/154258 VERSA HD/18578-002/154449 VERSA HD/18578-005/154807 VERSA HD/12457-003/154148 VERSA HD/12537-004/109028 VERSA HD/10278-002/156022 VERSA HD/10278-001/154947 ELEKTA SYNERGY/13185-F06501/151852 ELEKTA AXESSE/10795-K08501/152366 ELEKTA SYNERGY/11863-B03601/152069 VERSA HD/10376-002/153711 VERSA HD/10376-003/153706 ELEKTA SYNERGY/10194-001/153580 ELEKTA SYNERGY/10993-M06501/152417 ELEKTA SYNERGY/10993-M06601/152565 VERSA HD/10993-M06101/153359 VERSA HD/18404-D07701/153106 VERSA HD/11488-S07701/153279 VERSA HD/11735-D04701/154057 ELEKTA SYNERGY/18480-002/153856 VERSA HD/30001101-S17501/153249 VERSA HD/30003074-K12502/154383 ELEKTA SYNERGY/12455-A01701/152630 VERSA HD/12455-A01801/154530 ELEKTA SYNERGY/11153-A03601/151455 ELEKTA SYNERGY/11153-A03501/151429 VERSA HD/13192-E03502/154750 IGUIDE¿ 2.2.2 FCO MOD KIT/13192-E03501/2.2.2 VERSA HD/18474-002/154774 VERSA HD/18474-003/154982 VERSA HD/10719-T01701/153765 ELEKTA SYNERGY/10719-T01017/151846 ELEKTA SYNERGY/11653-W02501/151009 ELEKTA SYNERGY/11653-W02601/152584 VERSA HD/30004402-LIN001/154815 ELEKTA SYNERGY/11095-003/151576 VERSA HD/30003361-LIN001/154369 VERSA HD/10125-V-SELT/154167 VERSA HD/10125-V-SIGN/154226 iGUIDE Software/ACCOUNT-LOCATION/2.2.0 ELEKTA SYNERGY/12456-004/152779 VERSA HD/30003351-001/154306 VERSA HD/18650-001/154593 VERSA HD/30003382-001/154257 VERSA HD/30003225-001/154285 iGUIDE Software/ACCOUNT-LOCATION/2.2.0 ELEKTA AXESSE/18649-001/152519 VERSA HD/30003199-001/154225 VERSA HD/30003223-001/154320 VERSA HD/30002974-001/153455 VERSA HD/30001991-001/154412 VERSA HD/18280-002/154792 VERSA HD/30004177-001/154615 VERSA HD/30003093-001/154400 VERSA HD/30003093-002/154401 ELEKTA INFINITY/30003093-004/154403 VERSA HD/30003030-001/154233 VERSA HD/30003838-001/154541 VERSA HD/16686-002/154214 VERSA HD/16809-002/154839 ELEKTA SYNERGY/30001993-001/153533 VERSA HD/18630-002/154875 VERSA HD/30001597-001/154462 VERSA HD/30004346-001/154768 VERSA HD/10930-001/154142 ELEKTA SYNERGY/13206-002/152460 VERSA HD/30004237-LIN001/154714 VERSA HD/17373-LIN002/154284 iGUIDE Software/ACCOUNT-LOCATION/2.2.0 VERSA HD/18607-005/154990 VERSA HD/11755-005/154500 VERSA HD/11755-004/154279 VERSA HD/30003951-001/154598 ELEKTA SYNERGY/10924-002/151550 HexaPOD evo Module/11319-004/118046 VERSA HD/11320-004/156026 VERSA HD/11005-002/154236 VERSA HD/12576-003/154548 iGUIDE Software/12576-003/2.2.2 VERSA HD/10024-003/154984 VERSA HD/17416-002/154901 VERSA HD/12469-005/154174 VERSA HD/18753-001/154666 VERSA HD/17253-002/154824 VERSA HD/30000525-001/109023 VERSA HD/19242-003/154845 VERSA HD/30001314-001/154653 VERSA HD/30001635-002/154013 VERSA HD/17301-002/154629 VERSA HD/18743-001/153978 ELEKTA SYNERGY/10626-002/152895 VERSA HD/18784-002/156065 VERSA HD/18784-001/154930 ELEKTA SYNERGY/30000468-LIN001/154241 ELEKTA SYNERGY/30000468-LIN001/154241 ELEKTA INFINITY/15903-ONC001/153869 VERSA HD/16572-ONC001/153689 ELEKTA SYNERGY/16572-ONC002/153710 iGUIDE Software/30000332-ONC001/2.2.2 ELEKTA SYNERGY/16553-ONC001/152505 VERSA HD/30000330-ONC001/153905 VERSA HD/11612-LIN001/154254 ELEKTA INFINITY/15719-LIN001/154572 ELEKTA SYNERGY/16208-ONC001/153201 ELEKTA SYNERGY/13300-ONC001/151832 VERSA HD/13300-LIN002/154832 VERSA HD/12999-LIN001/154840 ELEKTA INFINITY/15940-LIN001/154159 VERSA HD/30000240-LIN001/154827 ELEKTA INFINITY/19930-LIN001/154209 ELEKTA INFINITY/16148-ONC001/154134 ELEKTA SYNERGY/30000390-LIN001/154256 ELEKTA SYNERGY/13324-ONC001/152762 VERSA HD/12600-LIN001/154436 VERSA HD/16194-LIN001/154849 Versa HD/16310-LIN002/109024 ELEKTA SYNERGY/16310-LIN001/154441 ELEKTA INFINITY/16222-ONC001/153677 ELEKTA SYNERGY/30000494-LIN001/154220 VERSA HD/15753-LIN001/154694 VERSA HD/16375-LIN001/154172 VERSA HD/12974-LIN002/154534 ELEKTA SYNERGY/15807-LIN001/154770 ELEKTA INFINITY/30000387-ONC001/153646 ELEKTA INFINITY/30000387-ONC001/153646 ELEKTA SYNERGY/16145-ONC001/152351 ELEKTA INFINITY/30000349-ONC001/153236 ELEKTA AXESSE/30000380-ONC001/153204 ELEKTA AXESSE/30000380-ONC001/153204 ELEKTA INFINITY/19933-LIN001/154208 ELEKTA SYNERGY/16386-LIN001/154782 VERSA HD/12266-LIN001/154481 ELEKTA AXESSE/30000602-ONC001/153102 ELEKTA SYNERGY/15933-LIN001/154326 ELEKTA SYNERGY/15933-LIN001/154326 VERSA HD/16225-ONC001/153998 IGUIDE¿ 2.2.2 FCO MOD KIT/10425-LIN001/2.2.2 VERSA HD/10425-LIN001/154628 ELEKTA INFINITY/15954-LIN001/154766 ELEKTA INFINITY/30000477-LIN001/153982 VERSA HD/30003036-LIN001/153776 ELEKTA SYNERGY/15614-ONC001/152260 VERSA HD/10375-ONC002/154679 VERSA HD/16578-LIN001/154812 VERSA HD/15861-LIN001/154158 ELEKTA SYNERGY/30002370-LIN001/154196 ELEKTA SYNERGY/11390-ONC001/154157 ELEKTA SYNERGY/17389-ONC001/152624 iGUIDE Software/17389-ONC001/2.2.2 VERSA HD/30000917-LIN001/154648 ELEKTA INFINITY/16262-LIN001/154213 VERSA HD/16267-LIN001/154200 ELEKTA SYNERGY/12749-ONC001/151596 VERSA HD/30001318-LIN001/154532 ELEKTA SYNERGY/15760-ONC001/154160 ELEKTA INFINITY/15916-LIN003/154516 Versa HD/30000498-LIN001/109039 VERSA HD/15850-LIN001/154197 VERSA HD/16403-LIN001/109032 ELEKTA SYNERGY/16366-LIN001/154538 ELEKTA SYNERGY/16730-LIN001/154223 VERSA HD/16730-LIN002/154222 VERSA HD/11686-007/154291 VERSA HD/11745-LIN001/154588 VERSA HD/30004417-LIN001/154846 VERSA HD/19028-LIN001/154919 VERSA HD/15471-LIN001/154492 VERSA HD/11998-LIN001/154430 ELEKTA INFINITY/30003850-LIN001/154560 VERSA HD/17033-LIN008/154751 ELEKTA INFINITY/17033-006/153294 VERSA HD/40021-LIN002/156025 VERSA HD/30004435-LIN001/154939 VERSA HD/17260-LIN002/154624 ELEKTA INFINITY/30002792-001/153748 ELEKTA INFINITY/30003292-001/154467 VERSA HD/12532-005/154239 VERSA HD/11461-L6new/154731 VERSA HD/11461-L8new/154511 VERSA HD/11771-AntHL2/154150 VERSA HD/11014-UMCU7N/154795 ELEKTA AXESSE/11014-UMCU15/152754 ELEKTA SYNERGY/13058-002/152161 ELEKTA SYNERGY/13058-003/152455 VERSA HD/13058-004/109012 VERSA HD/30000993-LIN001/109004 VERSA HD/30000993-LIN002/109017 VERSA HD/14926-004/154039 VERSA HD/20991-002/153163 VERSA HD/20991-001/153130 VERSA HD/14808-LIN001/109015 ELEKTA SYNERGY/13351-001/151966 VERSA HD/11412-004/154836 iGUIDE Software/12929-OPO801/2.2.2 VERSA HD/12929-LIN001/154890 VERSA HD/30003526-501/154686 VERSA HD/30003526-601/154716 iGUIDE Software/17176-KIE501/2.2.2 VERSA HD/17176-LIN001/154888 VERSA HD/12619-WAR801/154778 VERSA HD/12619-WAR901/154911 VERSA HD/30003322-WIM501/154251 VERSA HD/30003322-WIM601/154252 ELEKTA INFINITY/30003322-LIN001/154889 VERSA HD/12439-003/154763 ELEKTA INFINITY/18974-501/154837 VERSA HD/13041-LIN001/154921 VERSA HD/18959-LIN001/154975 VERSA HD/12475-LJU08/153679 IGUIDE¿ 2.2.2 FCO MOD KIT/30003117-001/2.2.2 VERSA HD/30003117-001/154438 VERSA HD/30003263-001/154935 ELEKTA INFINITY/12558-002/153631 IGUIDE¿ 2.2.2 FCO MOD KIT/30003724-001/2.2.2 VERSA HD/18521-002/154732 VERSA HD/18524-001/154681 VERSA HD/18527-001/154373 VERSA HD/30004046-001/154596 ELEKTA INFINITY/30001015-002/154468 VERSA HD/10708-001/154687 VERSA HD/18509-001/154513 VERSA HD/11261-003/154913 VERSA HD/10860-004/154124 VERSA HD/11071-005/154544 VERSA HD/13373-002/156004 VERSA HD/18534-001/154777 VERSA HD/30002863-001/154333 VERSA HD/10142-001/154706 VERSA HD/15020-04/154219 VERSA HD/15020-03/154529 iGUIDE Software/15020-04/2.2.2 VERSA HD/10157-013/154867 VERSA HD/10157-014/154862 VERSA HD/19658-RIV01/152951 VERSA HD/30004475-LIN001/154971 VERSA HD/10283-LIN002/154929 VERSA HD/16913-001/154739 VERSA HD/11487-LIN004/154542 ELEKTA INFINITY/30001447-LIN002/154780 VERSA HD/16909-LIN003/154406 VERSA HD/10498-LIN003/154678 VERSA HD/10620-LIN001/154811 VERSA HD/10620-LIN002/154794 iGUIDE Software/30003464-001/2.2.2.0 VERSA HD/30003464-001/154456 VERSA HD/30004284-001/154738 VERSA HD/30002988-001/154112 VERSA HD/30002988-001/154112 VERSA HD/30003000-001/154682 VERSA HD/30004023-001/154576 VERSA HD/10472-010/154354 IGUIDE¿ 2.2.2 FCO MOD KIT/13271-014/2.2.2 VERSA HD/13271-015/154689 ELEKTA SYNERGY/11407-011/152890 VERSA HD/10886-021/156063 ELEKTA SYNERGY/10886-012/151827 ELEKTA SYNERGY/11630-012/153212 ELEKTA SYNERGY/11489-016/151556 VERSA HD/30002724-01/154207 VERSA HD/30002724-03/154494 VERSA HD/30002724-02/154647 VERSA HD/11637-012/154347 VERSA HD/11637-013/154702 VERSA HD/30002401-001/154063 ELEKTA SYNERGY/10622-001/152822 VERSA HD/17023-001/154886 VERSA HD/12873-003/154755 VERSA HD/30000021-002/154843 VERSA HD/14117-001/153376 VERSA HD/14117-003/154559 VERSA HD/14117-004/154709 VERSA HD/11746-012/154426 ELEKTA INFINITY/13991-001/153072 ELEKTA INFINITY/11090-006/154244 VERSA HD/30000095-002/154697 VERSA HD/10434-003/153752 VERSA HD/13570-002/153847 VERSA HD/13570-003/154193 VERSA HD/11876-007/154501 VERSA HD/11876-008/154887 iGUIDE Workstation/14147-RO00/CLHD7T2 ELEKTA INFINITY/13851-001/154604 ELEKTA INFINITY/13851-002/154204 ELEKTA INFINITY/13852-001/154422 ELEKTA INFINITY/30000354-001/153342 ELEKTA INFINITY/30000354-002/153536 ELEKTA INFINITY/13571-001/154916 ELEKTA INFINITY/13523-001/154206 VERSA HD/10451-004/154105 VERSA HD/11923-003/154413 VERSA HD/30003099-001/154372 VERSA HD/30004313-001/154879 VERSA HD/30004307-001/154892 ELEKTA INFINITY/30000702-001/153164 ELEKTA INFINITY/30000149-001/152801 ELEKTA INFINITY/30000150-001/152970 ELEKTA SYNERGY/13177-001/151969 ELEKTA SYNERGY/14568-001/151782 VERSA HD/14261-002/154733 IGUIDE¿ 2.2.2 FCO MOD KIT/98300-001/2.2.2 VERSA HD/14386-001/154280 VERSA HD/11635-002/154388 VERSA HD/11707-007/153991 VERSA HD/30004075-001/154613 VERSA HD/10817-010/153986 VERSA HD/10559-002/153340 VERSA HD/19465-001/154111 ELEKTA SYNERGY/12776-001/151722 VERSA HD/10064-010/153997 ELEKTA INFINITY/15053-002/152792 VERSA HD/30004347-002/153841 VERSA HD/30004347-002/153841 VERSA HD/10255-009/153843 ELEKTA INFINITY/30004150-001/154640 ELEKTA INFINITY/30004150-002/154708 ELEKTA INFINITY/10877-008/152732 ELEKTA INFINITY/10877-009/152833 ELEKTA SYNERGY/12041-002/151714 ELEKTA INFINITY/17096-001/154117 iGUIDE Workstation/30001324-001/JMRX3J2 VERSA HD/13120-008/153187 ELEKTA INFINITY/14131-001/154069 VERSA HD/14402-002/154719 VERSA HD/13728-003/154070 ELEKTA SYNERGY/10632-006/152468 VERSA HD/10632-004/153890 VERSA HD/10632-007/154710 ELEKTA INFINITY/13272-002/154182 VERSA HD/13267-002/153466 ELEKTA INFINITY/12131-002/152798 ELEKTA SYNERGY/12131-001/151410 VERSA HD/14175-004/154323 VERSA HD/14175-004/154323 ELEKTA AXESSE/11798-008/151952 ELEKTA SYNERGY/10303-005/153552 VERSA HD/30000068-001/154852 ELEKTA INFINITY/13777-002/153826 ELEKTA INFINITY/13797-001/152371 ELEKTA INFINITY/12015-003/154132 ELEKTA INFINITY/13725-001/154370 ELEKTA SYNERGY/30000194-002/151774 Versa HD/10228-004/154793 ELEKTA INFINITY/13866-001/152158 VERSA HD/13866-003/154217 ELEKTA INFINITY/15087-001/152392 ELEKTA SYNERGY/15087-003/153867 ELEKTA INFINITY/14707-001/154051 VERSA HD/10150-006/154711 VERSA HD/30000680-001/153295 ELEKTA AXESSE/11944-003/151793 VERSA HD/11944-004/153903 VERSA HD/30003708-001/154601 VERSA HD/12115-004/154190 VERSA HD/11193-003/154418 VERSA HD/10691-002/153858 VERSA HD/10342-005/154185 ELEKTA INFINITY/30003193-002/154986 VERSA HD/30002646-001/154085 VERSA HD/13546-001/154339 VERSA HD/13546-002/154340 ELEKTA INFINITY/15473-001/152200 ELEKTA SYNERGY/13314-002/152116 ELEKTA SYNERGY/11441-020/151412 VERSA HD/13359-003/154420 VERSA HD/13359-004/154419 ELEKTA SYNERGY/10356-008/152307 VERSA HD/10356-011/153897 ELEKTA SYNERGY/13212-002/151882 VERSA HD/14593-002/154243 VERSA HD/11017-008/154518 VERSA HD/11017-009/154908 VERSA HD/11638-007/154431 VERSA HD/30000079-001/154178 ELEKTA SYNERGY/13572-003/151885 ELEKTA AXESSE/10193-008/151812 VERSA HD/11076-003/153832 VERSA HD/12099-003/154046 VERSA HD/12099-004/153625 ELEKTA SYNERGY/10714-011/152522 VERSA HD/10492-LIN003/154349 ELEKTA SYNERGY/10492-LIN002/154356 VERSA HD/10492-LIN003/154349 ELEKTA INFINITY/16922-LIN002/154762 ELEKTA INFINITY/19112-LIN002/154265 VERSA HD/19112-LIN005/154925 
Recalling Firm/
Manufacturer		 Medical Intelligence Medizintechnik Gmbh
Robert-bosch-str. 8
Schwabmunchen Germany
For Additional Information Contact Alejandra Carrillo
770-670-2359
Manufacturer Reason
for Recall		 Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
FDA Determined
Cause 2		 Software design
Action The firm sent an Urgent Important Field Safety Notification letter dated July 2019 via email. The identified the affected product, problem and actions to be taken. Customers were instructed to post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and advise the appropriate personnel, working with this product, on the content of this letter.
Quantity in Commerce 496 units
Distribution Worldwide Distribution - US Nationwide
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 = MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
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