Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All;
  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:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for Recall:
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Product Codes/Lot Numbers:

System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1350-2026

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