The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1151-2020·Announced 2020-02-19

MEDTECH ROSA One 3.1 Brain Application Recalled for Image Reconstruction Errors

MEDTECH SAS is recalling 39 units of the ROSA One 3.1 Brain Application 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 involves a medical device defect that potentially compromises surgery planning, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

MEDTECH SAS is recalling 39 units of the ROSA One 3.1 Brain Application. 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 specific serial numbers and UDI numbers for the affected units are listed in the agency's recall record.

Healthcare providers should stop using the affected software and contact MEDTECH SAS for instructions on corrective actions.

The recalled product

Product
ROSA One 3.1 Brain Application
Manufacturer
MEDTECH SAS
Category
Medical Device — Surgical Planning Software
Hazard
Affected units
39

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 (11)

  • 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.

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 →

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