Medical Intelligence Medizintechnik Gmbh recalls IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Pro

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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