Philips OmniLab Advanced+ Intl recall
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome…
Why was Philips OmniLab Advanced+ Intl recalled?
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome…
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 34 units ***updated January 2024 *** additional 3 units
- 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.
- Recall date
- September 14, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)