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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Philips Respironics, Inc.: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

Agency Publication Date: July 15, 2021
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Affected Products

Product: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1040001 1054096 1054097 1054260 1054655 1058180 1119867 1040001B 1054096B 1054096NB 1054097B 1054260B 1054655B 1054655TP 1054655TPV 1058180B AU1054096 AU1054096B BR1054096 BT1054096 BT1054260 CA1054096 CA1054096B CN1054096 IT1054096B KO1054096 KR1054096 LA1054096 LG1054096 R1054096 R1054096B R1054097 R1054097B R1054260 R1054260B R1054655 R1054655B R1054655TP R1054655TPV R1119867 RSL1054260 RSL1054260B RTO1054260 RTO1054260B U1054096 U1054096B U1054097 U1054097B U1054260 U1054260B U1054655 RBR1054096 RTO1119867 1032800 1032802 1032804 1040002 1040005 1032800B 1032802B 1032804B 1032804TP 1032804TPV 1040002B 1040005B 1125564B AU1032800 AU1032800B BR1032800 CA1032800 CA1032800B IT1032800B KO1032800 KR1032800 LA1032800 LG1032800 R1032800 R1032802 R1032804 R1032804B R1032804TP R1032804TPV R1040005 R1040005B RTO1040005B SP1032800B U1032800 U1032802 U1032804 U1040005 U1040005B

Product: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671

Product: A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1076492 1076493 1076495 1076538 1076539 1076565 1076566 1076579 1076580 1076583 1076584 1076586 1078226 1078297 1104171 1111168 1111169 1111170 1111171 1111172 1111173 1111174 1111175 1111176 1111177 1116156 1122129 1140798 1140799 1111170S 1111170-S AR1111169 BR1076493 BR1076566 BR1111169 CN1076493 CN1076566 CN1111169 GB-SPK0011 GB-SPK0012 IT1111169 LA1076493 LA1076566 R1076495 R1111169 R1111177 R1116156 1104170 R1111175 RBR1111169 U1116156 1038916 1038917 1040716 1044114 1044235 1038987 1040717 1068942 1068943 1042900 1042901 1042903 1042904 1042906 1042907 1044288 1044289 1040718 1067255 1029744 1029750 1029756 1029757 1029758 1029759 AU1029756 CA1029756 CA1029759 LA1029756 1030075 1055770 1055813

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88071
Status: Active
Manufacturer: Philips Respironics, Inc.
Manufactured In: United States
Units Affected: 3 products (255810; 8047; 72665)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.