Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Azurion 2.1(L1) and 2.1(L2)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Philips Healthcare
- Reason for Recall:
- 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Product Codes/Lot Numbers:
Azurion 2.1(L1) and 2.1(L2)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0238-2022
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