Recall archive / FDA device enforcement
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patie... — FDA record Z-1659-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 26, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Reason
- Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- Classification
- Class I
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 8 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1659-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 606959067837, 606959068001; Model No.: 1111124, R1111124; Serial No. L29084645477C, L303986771E8D, L303987043BC2, L3039871356A5, L30398768A57E, L303987892EE7, L30398795FD53, L30398849CD80 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Aug 26, 2022
- Center classification date
- Sep 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.