Medtech ROSA Brain 3.0 Software Recalled for Image Reconstruction Errors
Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm to patients during surgery planning due to software errors, but no injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtech SAS is recalling 47 units of the ROSA Brain 3.0 Application-Brain software. The recall is due to a defect where some cross-sectional images from patient head acquisitions may not be reconstructed or displayed properly in two and three-dimensional views.
This issue potentially compromises surgery planning. The affected units were distributed nationwide in the United States. The source text does not report any illnesses or injuries associated with this recall.
Hospitals and healthcare facilities should check their inventory for the specific serial numbers and UDI codes listed in the official recall notice. Users should contact Medtech SAS for instructions on how to proceed with the recall.
The recalled product
- Product
- ROSA Brain 3.0 Application-Brain
- Manufacturer
- MEDTECH SAS
- Category
- Medical Device — Software
- Affected units
- 47
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: BR16004
- BR16005
- BR16006
- BR16009
- BR16010
- BR16011
- BR16012
- BR16014
- BR16015
- BR16016
- BR16017
- BR16018
- BR16021
- BR16023
- BR16025
- BS16904
- BS16905
- BS16910
- BS16916
- BS16917
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MEDTECH SAS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · MEDTECH SAS
See all →- CriticalSurgical Brain Guidance System Recalled for Inaccurate Electrode Placement
FDA (Devices) · 2021-11-03
- HighMEDTECH ROSA One 3.1 Brain Application Recalled for Image Reconstruction Errors
FDA (Devices) · 2020-02-19
- SevereMedtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors
FDA (Devices) · 2019-11-13
- ModerateMedtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues
FDA (Devices) · 2018-06-13
Same hazard · software defect
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- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
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Similar recalls
- SevereMedtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors
FDA (Devices) · 2019-11-13
- ModerateMedtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues
FDA (Devices) · 2018-06-13
- CriticalSurgical Brain Guidance System Recalled for Inaccurate Electrode Placement
FDA (Devices) · 2021-11-03
- SevereROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors
FDA (Devices) · 2018-02-28
- HighSiemens syngo.via RT Image Suite Software Recall for Geometry Errors
FDA (Devices) · 2020-07-29
- ModerateZimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices
FDA (Devices) · 2017-04-19