Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 606959028791; Model No.: 1109581; Serial No. L28664716B714, L28664717A69D, L286647185E6A, L286647194FE3, L28664720F84A, L28664721E9C3, L28664722DB58, L28664723CAD1, L28664724BE6E, L28870984130F, L288709850286, L28870986301D, L288709872194, L28870988D963, L28870989C8EA, L288709904CF3, L288709915D7A, L288709926FE1, L288709937E68, L288709940AD7, L288709951B5E, L2887099629C5, L28870997384C, L28870998C0BB, L28870999D132, L288710001B4E, L288710010AC7, L28871002385C, L2887100329D5, L288710045D6A, L288710054CE3, L288710067E78, L288710076FF1, L288710089706, L28871009868F, L288710100296, L288710122184, L28871013300D, L2887101444B2, L28871015553B, L2887101667A0, L288710177629, L288710188EDE, L288710199F57, L2887102028FE, L288710213977, L288710220BEC, L288710231A65, L288710246EDA, L288710257F53, L288710264DC8, L288710275C41, L28871028A4B6, L28871029B53F, L288710303126, L2887103120AF, L288710321234, L2887103303BD, L290846327ECB, L290846336F42, L290846341BFD, L290846350A74, L2908463638EF, L29084638D191, L29084639C018, L2908464010D1, L290846410158, L2908464233C3, L29084643224A, L2908464456F5, L2908464675E7, L29084647646E, L290846489C99, L290846498D10, L290846500909, L290846511880, L290846522A1B, L290846533B92, L290846544F2D, L290846555EA4, L290846566C3F, L303986996DE3, L30398708F1AE, L3039884141C8, L304097046ACC
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Product Codes/Lot Numbers:
UDI-DI: 606959028791; Model No.: 1109581; Serial No. L28664716B714, L28664717A69D, L286647185E6A, L286647194FE3, L28664720F84A, L28664721E9C3, L28664722DB58, L28664723CAD1, L28664724BE6E, L28870984130F, L288709850286, L28870986301D, L288709872194, L28870988D963, L28870989C8EA, L288709904CF3, L288709915D7A, L288709926FE1, L288709937E68, L288709940AD7, L288709951B5E, L2887099629C5, L28870997384C, L28870998C0BB, L28870999D132, L288710001B4E, L288710010AC7, L28871002385C, L2887100329D5, L288710045D6A, L288710054CE3, L288710067E78, L288710076FF1, L288710089706, L28871009868F, L288710100296, L288710122184, L28871013300D, L2887101444B2, L28871015553B, L2887101667A0, L288710177629, L288710188EDE, L288710199F57, L2887102028FE, L288710213977, L288710220BEC, L288710231A65, L288710246EDA, L288710257F53, L288710264DC8, L288710275C41, L28871028A4B6, L28871029B53F, L288710303126, L2887103120AF, L288710321234, L2887103303BD, L290846327ECB, L290846336F42, L290846341BFD, L290846350A74, L2908463638EF, L29084638D191, L29084639C018, L2908464010D1, L290846410158, L2908464233C3, L29084643224A, L2908464456F5, L2908464675E7, L29084647646E, L290846489C99, L290846498D10, L290846500909, L290846511880, L290846522A1B, L290846533B92, L290846544F2D, L290846555EA4, L290846566C3F, L303986996DE3, L30398708F1AE, L3039884141C8, L304097046ACC
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1657-2022
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