FDA-Device2024-05-29Class I
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Hazard
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
Sold states
US Nationwide distribution and OUS International distribution to Canada.
Affected count
9,388 US; 2,664 ROW
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1817-2024More Philips Respironics, Inc. recalls
- FDA-Device2026-04-08Philips Respironics Trilogy Evo O2 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo Universal ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy EV300 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-01Philips Respironics Trilogy Evo ventilator recalled for inaccurate breath volume delivery with certain nebulizers
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