🔍 RecallPedia

Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Class I - Dangerous
🏥 Medical Devices Recalled: August 26, 2022 Philips Respironics Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 606959029415, 606959028791; Model No.: 1109582, 1109585; Serial No. L28664715858F, L286647269D7C, L286647278CF5, L28870204F469, L28870206D77B, L28870207C6F2, L288702092F8C, L28870210AB95, L28870211BA1C, L288702128887, L28870214EDB1, L28870215FC38, L28870216CEA3, L28870217DF2A, L290843744520, L2908437554A9, L290843766632, L2908437777BB, L290843788F4C, L290843799EC5, L30396148EE55, L3039822431CF, L3039826456AF, L303982733BC8, L3039831335C4, L303983231FAC, L30398354261B, L30398416EE6C, L30398476BABC, L303984836ED9, L30398524BDCA, L30398531F3BF, L3039856810C6, L28664713E0B9; ***January 2024 Update *** L28664709563B, L28664710D222, L28664712F130;
  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:
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Product Codes/Lot Numbers:

UDI-DI: 606959029415, 606959028791; Model No.: 1109582, 1109585; Serial No. L28664715858F, L286647269D7C, L286647278CF5, L28870204F469, L28870206D77B, L28870207C6F2, L288702092F8C, L28870210AB95, L28870211BA1C, L288702128887, L28870214EDB1, L28870215FC38, L28870216CEA3, L28870217DF2A, L290843744520, L2908437554A9, L290843766632, L2908437777BB, L290843788F4C, L290843799EC5, L30396148EE55, L3039822431CF, L3039826456AF, L303982733BC8, L3039831335C4, L303983231FAC, L30398354261B, L30398416EE6C, L30398476BABC, L303984836ED9, L30398524BDCA, L30398531F3BF, L3039856810C6, L28664713E0B9; ***January 2024 Update *** L28664709563B, L28664710D222, L28664712F130;

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1658-2022

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