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

Hazard

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Details from the source

Reason for recall: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. 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, Quantity: 34 units ***updated January 2024 *** additional 3 units Lot/code info: 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;

UPC codes

606959029415, 606959028791

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.