ROSA Brain 3.0 Application-Brain recall: Software Issue
ROSA Brain 3.0 Application-Brain
Why was ROSA Brain 3.0 Application-Brain recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ROSA Brain 3.0 Application-Brain
- Recalling firm
- MEDTECH SAS
- Quantity
- 47 units
- Distribution
- US Nationwide
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)