OLEA MEDICAL recall records

1 reported ongoing

1 records in this archive. Latest source date Aug 10, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Functional MR V1.0

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 le...

Class IIReported ongoing

Distribution: US: MI, MA

Official source for Functional MR V1.0

Reasons in these listed records

  • 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 misinterpret...

These examples come from this result page and are not a ranking of every recall reason.

Checking OLEA MEDICAL

Is there a recall on olea medical right now?

This archive contains 1 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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