🔍 RecallPedia

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Class I - Dangerous
🏥 Medical Devices Recalled: November 26, 2021 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All units are impacted
  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 Llc
Reason for Recall:
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Product Codes/Lot Numbers:

All units are impacted

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0505-2022

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