The Recall Desk
HighFDA (Devices)·Z-1150-2020·Announced 2020-02-19

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.

What this means for you

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
Hazard
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

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Same hazard · software defect

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