ALLURA Xper FD10F; System Code: 722002;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    System Code: 722002; UDI: N/A; System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40;
  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:
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ALLURA Xper FD10F; System Code: 722002;

Product Codes/Lot Numbers:

System Code: 722002; UDI: N/A; System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1660-2026

Related Recalls

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Dec 7, 2023 Other Medical Devices Nationwide View Details →

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Dec 7, 2023 Other Medical Devices Nationwide View Details →

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Dec 7, 2023 Other Medical Devices Nationwide View Details →