FDA Medical Device Recalls (openFDA)
OLEA MEDICAL: Functional MR V1.0
- Recall number
- Z-0122-2024
- Recalling firm
- OLEA MEDICAL
- Product
- Functional MR V1.0
- Status
- Open, Classified
- Initiated
- 2023-08-10
- Posted
- 2023-10-18
- Terminated
- not on file
- Reason
- 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
- 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 qa-ra@olea-medical.com
- Quantity
- 2
- Distribution
- US: MI, MA
- Lot, serial or model codes
- UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
- 510(k) numbers
- ["K221426"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3007675959
- Firm city
- LA CIOTAT
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28