{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schwabmunchen",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83358",
      "recalling_firm": "Medical Intelligence Medizintechnik Gmbh",
      "address_1": "Robert-bosch-str. 8",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "recall_number": "Z-2082-2019",
      "product_description": "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.",
      "product_quantity": "496 units",
      "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.",
      "recall_initiation_date": "20190718",
      "center_classification_date": "20190725",
      "termination_date": "20230811",
      "report_date": "20190731",
      "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 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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 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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"
    }
  ]
}