Summary
The FDA issued a Class II for Functional MR V1.0 by OLEA MEDICAL. Reason: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic res.
Details
Source
Device Recall
External ID
Z-0122-2024
Action Date
2023-10-25
Status
Ongoing
Category
device
Product Description
Functional MR V1.0
Lot/Code Info: UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
Quantity Affected: 2
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.
Distribution
US: MI, MA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
Company
LA CIOTAT, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
OLEA MEDICAL has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OLEA MEDICAL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OLEA MEDICAL have FDA actions?
OLEA MEDICAL has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0122-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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