🔍 RecallPedia

Therapy Mask 3100 NC/SP

Class I - Dangerous
🏥 Medical Devices Recalled: September 6, 2022 Philips Respironics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.
  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 Respironics, Inc.
Reason for Recall:
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Therapy Mask 3100 NC/SP

Product Codes/Lot Numbers:

All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1784-2022

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