OLEA MEDICAL: Medical Device Recall in 2023 - (Recall #: Z-0122-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Functional MR V1.0

Product Classification:

Class II

Date Initiated: August 10, 2023

Date Posted: October 25, 2023

Recall Number: Z-0122-2024

Event ID: 93049

Reason for Recall:

When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.

Status: Ongoing

Product Quantity: 2

Code Information:

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

Distribution Pattern:

US: MI, MA

Voluntary or Mandated:

Voluntary: Firm initiated