FDA Device Recall Z-1658-2022

Philips Respironics, Inc. · Murrysville, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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;

Quantity: 34 units ***updated January 2024 *** additional 3 units

Reason for recall

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

Recall record

Recall number: Z-1658-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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 initiated: 2022-08-26
Classified by FDA Center: 2022-09-08
FDA published: 2022-09-14
Recalling firm: Philips Respironics, Inc.
Firm location: Murrysville, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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