ROSA Brain 3.0 Application-Brain
Check against the official notice below — it lists the full affected range.
MedTech SAS has recalled the ROSA Brain 3.0 Application-Brain software due to a defect in which some cross-sectional images from patient head scans may not reconstruct or display properly in two and three-dimensional views. This malfunction could compromise surgical planning, as surgeons may not have accurate image data when preparing for brain procedures. The recall affects 47 units distributed nationwide across the United States.
The affected units are identified by specific serial numbers and UDI codes ranging from BR16004 through BR18051 and related BS-series units produced between 2016 and 2018. According to the recall record, no remedy information has been specified.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide Quantity: 47 units Lot/code info: 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,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.