Z-1657-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- August 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
Product Description
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Reason for Recall
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Distribution Pattern
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.
Code Information
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