CLASS II ONGOING Device recall · Reported 25 Oct 2023 · FDA Enforcement Report
Functional MR V1.0 recalled by Olea Medical
Olea Medical is recalling Functional MR V1.0, distributed in Massachusetts, Michigan. The recall was initiated on 10 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0122-2024
- FDA event ID
- 93049
- Recalling firm
- Olea Medical, LA CIOTAT, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Aug 2023
- FDA classified
- 18 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2023 | Recall initiated by company | |
| 18 Oct 2023 | Classified by FDA | +69 days |
| 25 Oct 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Functional MR V1.0
Where it was distributed
US: MI, MA
Questions about this recall
Is Functional MR V1.0 recalled?
Yes. Olea Medical recalled Functional MR V1.0 on 10 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0122-2024.
Why was it recalled?
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.
Which lots are affected?
UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
Where was it sold?
US: MI, MA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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