🔍 RecallPedia

Integris-Allura IGTS Fixed Systems

Class I - Dangerous
🏥 Medical Devices Recalled: October 4, 2023 Philips North America Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    INTEGRIS Allura 15-12 (mono) 68
  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 North America
Reason for Recall:
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Integris-Allura IGTS Fixed Systems

Product Codes/Lot Numbers:

INTEGRIS Allura 15-12 (mono) 68

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0227-2024

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