Allura Xper FD20/10; System Code: 722029;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    System Code: 722029; UDI: 00884838059078; System Serial Number: 57, 7, 88, 56, 126, 94, 30, 31, 21, 97, 91, 110, 100, 63, 60, 55, 62, 129, 71, 36, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 127, 14, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 50, 51, 124, 87, 20, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;
  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 FD20/10; System Code: 722029;

Product Codes/Lot Numbers:

System Code: 722029; UDI: 00884838059078; System Serial Number: 57, 7, 88, 56, 126, 94, 30, 31, 21, 97, 91, 110, 100, 63, 60, 55, 62, 129, 71, 36, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 127, 14, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 50, 51, 124, 87, 20, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1668-2026

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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.

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