MEDTECH SAS Recalls ROSA Brain 3.0 Application-Brain: Image Reconstruction Errors May
MEDTECH SAS recalls ROSA Brain 3.0 Application-Brain software with specific serial numbers due to potential image reconstruction errors that could compromise surgery planning. Affected units include 70 serial numbers listed in the recall notice.
Lower-risk 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.
Contact the company
What happened, in plain English
MEDTECH SAS is recalling specific versions of their ROSA Brain 3.0 Application-Brain software because some cross-sectional images from patient head scans may not display correctly in 2D or 3D views during surgery planning. This could lead to inaccurate surgical planning if the software fails to properly reconstruct images. Read more at govinfonow.com/recall/66159-medtech-sas-recalls-rosa-brain-3-0-application-brain-image.
Source Summary by GovInfoNow · govinfonow.com/recall/66159-medtech-sas-recalls-rosa-brain-3-0-application-brain-image · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1150-2020
Cite this page
“MEDTECH SAS Recalls ROSA Brain 3.0 Application-Brain: Image Reconstruction Errors May.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/66159-medtech-sas-recalls-rosa-brain-3-0-application-brain-image. Based on FDA recall #Z-1150-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1150-2020%22&limit=1).
Why it’s dangerous
The software may fail to correctly reconstruct and display cross-sectional images from patient head scans when viewed in two or three dimensions. This could lead to inaccurate surgical planning if the images are not properly visualized during the planning phase.
Who’s affected
Surgical teams using the recalled ROSA Brain 3.0 Application-Brain software for patient head imaging. The risk is primarily for medical professionals who rely on this software for precise surgical planning.
How to tell if you have this one
Check if your ROSA Brain 3.0 Application-Brain software has one of the 70 listed serial numbers. The recall includes specific serial numbers and their corresponding UDI codes as detailed in the notice.
- Brand
MEDTECH SAS- Product
ROSA Brain 3.0 Application-Brain- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1150-2020 | ROSA Brain 3.0 Application-Brain; 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 | 47 units |
| Z-1151-2020 | ROSA One 3.1 Brain Application; Serial Number / UDI Number: 1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037; 2) BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038; 3) BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039; 4) BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040; 5) BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041; 6) BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043; 7) BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049; 8) BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050; 9) BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052; 10) BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054; 11) BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057; 12) BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058. | 39 units |
What to do — step by step
Check Software Version
Verify your software version matches the recalled ROSA Brain 3.0 Application-Brain version with the listed serial numbers.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1150-2020 (January 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1150-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.