Reported Sep 14, 2022 · Ongoing
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- 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 codes and dates
- UDI-DI
606959029415606959028791Model No.: 11095821109585Serial No. L28664715858FL286647269D7CL286647278CF5L28870204F469L28870206D77BL28870207C6F2L288702092F8CL28870210AB95L28870211BA1CL288702128887L28870214EDB1L28870215FC38L28870216CEA3L28870217DF2AL290843744520L2908437554A9L290843766632L2908437777BBL290843788F4CL290843799EC5L30396148EE55L3039822431CFL3039826456AFL303982733BC8L3039831335C4L303983231FACL30398354261BL30398416EE6CL30398476BABCL303984836ED9L30398524BDCAL30398531F3BFL3039856810C6L28664713E0B9***January 2024 Update *** L28664709563BL28664710D222L28664712F130
- UDI-DI
- Amount recalled
- 34 units ***updated January 2024 *** additional 3 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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