ROSA Brain 3.0 Application-Brain

Reason: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

Code information: Serial Numbers: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16025, BS16904, BS16905, BS16910, BS16916, BS16917, BS16923, Additional Serial Numbers / UDI: 1) BR17030 / UDI - (01)03760244031754(11)180309(21)BR17030; 2) BR17034, BS17934 / UDI - (01)03760244031754(11)180315(21)BR17034; 3) BR17035, BS17935 / UDI - (01)03760244031754(11)180315(21)BR17035; 4) BR17036 / UDI - (01)03760244031754(11)180417(21)BR17036; 5) BR17037, BS17937 / UDI - (01)03760244031754(11)180313(21)BR17037; 6) BR18024 / UDI - (01)03760244031754(11)180321(21)BR18024; 7) BR18031 / UDI - (01)03760244031754(11)180309(21)BR18031; 8) BR18038 / UDI - BS18938 "(01)03760244031754(11)180430(21)BR18038; 9) BR18039 / UDI - (01)03760244031754(11)180416(21)BR18039; 10) BR18040, BS18940 / UDI - (01)03760244031754(11)180427(21)BR18040; 11) BR18041, BS18941 / UDI - (01)03760244031754(11)180329(21)BR18041; 12) BR18042 / UDI - (01)03760244031754(11)180420(21)BR18042; 13) BR18043, BS18943 / UDI - (01)03760244031754(11)180503(21)BR18043; 14) BR18045, BS18945 / UDI - (01)03760244031754(11)180504(21)BR18045; 15) BR18046, BS18946 / UDI - (01)03760244031754(11)180515(21)BR18046; 16) BR18047 / UDI - (01)03760244031754(11)180413(21)BR18047; 17) BR18048, BS18948 / UDI - (01)03760244031754(11)180608(21)BR18048; 18) BR18049, BS18949 / UDI - (01)03760244031754(11)180625(21)BR18049; 19) BR18050 / UDI - (01)03760244031754(11)180531(21)BR18050; 20) BR18051, BS18951 / UDI - (01)03760244031754(11)180605(21)BR18051; 21) BR18052, BS18952 / UDI - (01)03760244031754(11)180621(21)BR18052; 22) BR18053 / UDI - (01)03760244031754(11)180718(21)BR18053; 23) BR18054 / UDI - (01)03760244031754(11)180710(21)BR18054; 24) BR18055 / UDI - (01)03760244031754(11)180605(21)BR18055; 25) BR18056, BS18956 / UDI - (01)03760244031754(11)180611(21)BR18056; 26) BR18057 / UDI - (01)03760244031754(11)180614(21)BR18057; 27) BR18058 / UDI - (01)03760244031754(11)180717(21)BR18058; 28) BR18059, BS18959 - UDI - (01)03760244031754(11)180627(21)BR18059; 29) BR18060 / UDI - (01)03760244031754(11)180627(21)BR18060; 30) BR18061, BS18961 / UDI - (01)03760244031754(11)180704(21)BR18061; 31) BR18062 / UDI - (01)03760244031754(11)180806(21)BR18062; 32) BR18063 / UDI - (01)03760244031754(11)180807(21)BR18063; 33) BR18064 / UDI - (01)03760244031754(11)180806(21)BR18064; 34) BR18065 / UDI - (01)03760244031754(11)180823(21)BR18065; 35) BR18066, BS18966 / UDI - (01)03760244031754(11)180827(21)BR18066; 36) BR18067 / UDI - (01)03760244031754(11)180903(21)BR18067; 37) BR18068, BS18968 / UDI - (01)03760244031754(11)180813(21)BR18068; 38) BR18069, BS18969 / UDI - (01)03760244031754(11)180820(21)BR18069; 39) BR18070, BS18970 / UDI - (01)03760244031754(11)180829(21)BR18070; 40) BR18071, BS18971 / UDI - (01)03760244031754(11)180904(21)BR18071; 41) BR18072, BS18972 / UDI - (01)03760244031754(11)180831(21)BR18072; 42) BR18073 / UDI - (01)03760244031754(11)180910(21)BR18073; 43) BR18074, BS18974 / UDI - (01)03760244031754(11)181108(21)BR18074; 44) BR18075, BS18975 / UDI - (01)03760244031754(11)180906(21)BR18075; 45) BR18076, BS18976 / UDI - (01)03760244031754(11)180907(21)BR18076; 46) BR18077, BS18977 / UDI - (01)03760244031754(11)180911(21)BR18077; 47) BR18078 / UDI - (01)03760244031754(11)180912(21)BR18078; 48) BR18079 / UDI - (01)03760244031754(11)180912(21)BR18079; 49) BR18080 / UDI - (01)03760244031754(11)180913(21)BR18080; 50) BR18081 / UDI - (01)03760244031754(11)180926(21)BR18081; 51) BR18082 / UDI - (01)03760244031754(11)181009(21)BR18082; 52) BR18083 / UDI - (01)03760244031754(11)181011(21)BR18083; 53) BR18084, BS18984 / UDI - (01)03760244031754(11)181108(21)BR18084; 54) BR18085 / UDI - (01)03760244031754(11)181017(21)BR18085; 55) BR18086, BS18986 / UDI - (01)03760244031754(11)181019(21)BR18086; 56) BR18087, BS18987 / UDI - (01)03760244031754(11)181112(21)BR18087; 57) BR18088, BS18988 / UDI - (01)03760244031754(11)181114(21)BR18088; 58) BR18089 / UDI - (01)03760244031754(11)181109(21)BR18089; 59) BR18090 / UDI - (01)03760244031754(11)181120(21)BR18090; 60) BR18091 / UDI - (01)03760244031754(11)181112(21)BR18091; 61) BR18092 / UDI - (01)03760244031754(11)181128(21)BR18092; 62) BR18093 / UDI - (01)03760244031754(11)181116(21)BR18093; 63) BR18094 / UDI - (01)03760244031754(11)181119(21)BR18094; 64) BR18095, BS18995 / UDI - (01)03760244031754(11)181121(21)BR18095; 65) BR18096, BS18996 / UDI - (01)03760244031754(11)181126(21)BR18096; 66) BR18097 / UDI - (01)03760244031754(11)181129(21)BR18097; 67) BR18098, BS18998 / UDI - (01)03760244031754(11)181123(21)BR18098; 68) BR18099 / UDI - (01)03760244031754(11)181211(21)BR18099; 69) BR18100 / UDI - (01)03760244031754(11)181217(21)BR18100; 70) BR18101 / UDI - (01)03760244031754(11)181221(21)13R18101

Distribution pattern: US Nationwide