🔍 RecallPedia

Functional MR V1.0

Class I - Dangerous
🏥 Medical Devices Recalled: August 10, 2023 OLEA MEDICAL Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
OLEA MEDICAL
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Functional MR V1.0

Product Codes/Lot Numbers:

UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3

Distribution:

Distributed in: US, MI, MA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0122-2024