Z-0122-2024Class II

Functional MR V1.0

Name: Z-0122-2024 Functional MR V1.0
Creator: Olea Medical
Published: 2023-08-10
License: https://open.fda.gov/license/

Olea Medical / initiated 2023-08-10 / Open, Classified / root cause: software

FDA source

OLEA MEDICAL began a recall of Functional MR V1.0 on 2023-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0122-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-10-18
Recalling firm: Olea Medical
Product: Functional MR V1.0
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: On 8/10/23, field safety notices were emailed to customers who were told to take the following actions: Advice for the user to detect if the bug occurred: This defect can be detected within the Functional MR V1.0 user interface by displaying the exported volume on an anatomical sequence. To detect the issue, the VOI shall be dragged and dropped from the data browser on an anatomical sequence, which will display a notification, indicating the original VOI s name. Outside of Functional MR V1.0 user interface, the user may check the DICOM tag "Segment Label (0062,0003)" in the viewer used, as this DICOM tag contains the correct VOI s name. Workaround: This problem can be overcome when exporting VOIs individually and has no impact on exporting VOIs merged with an anatomical map. New software will be available in October 2023. Complete and return the reply form via email to [email protected]
Quantity in commerce: 2
Distribution: US: MI, MA
Product codes and lots: UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0122-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0122-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-18

Product code LLZ

K221426Class IIFunctional MR V1.0Olea Medical S.A.S. / cleared 2022-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)