The Recall Desk
HighFDA (Devices)·Z-0122-2024·Announced 2023-10-25

Functional MRI Software Bug May Cause DICOM Export Data Mismatch

A software bug in Functional MR V1.0 can cause file contents and descriptions to not match when exporting multiple regions of interest in DICOM format, potentially leading to misinterpretation of clinical imaging data.

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: This is an FDA Class II recall with a theoretical risk of clinical data misinterpretation, but no reported adverse events or injuries. Per the severity rubric, Class II recalls without reported hospitalizations qualify as High (Score 3).

Plain-English summary

Functional MR V1.0 is a software application used for functional magnetic resonance imaging analysis, developed by OLEA MEDICAL. The software is affected by a bug when exporting regions of interest in DICOM SEGMENTATION format.

When multiple volumes of interest are exported simultaneously, the software may produce files where the contents and associated series descriptions do not match. This mismatch could lead to clinicians misinterpreting the imaging data. The affected software versions are V1.0, V1.0 SP1, V1.0 SP2, and V1.0 SP3.

The product has been distributed in Michigan and Massachusetts.

The recalled product

Product
Functional MR V1.0
Manufacturer
OLEA MEDICAL
Category
Medical Device — Medical Imaging Software
Hazard
  • data-mismatch
  • clinical-misinterpretation

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 (5)

  • UDI-DI: EOLEFMRIV1P00
  • Software Versions: V1.0
  • V1.0 SP1
  • V1.0 SP2
  • V1.0 SP3

Distribution

Distributed in 2 states:

  • MA
  • MI

Related recalls

Same category