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Philips Respironics, Inc. FDA Recalls
79 recalls on file across devices, 66 of them Class I and 73 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026In some situations, the Obstruction Alarm does not trigger w |
| Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026Using non-pneumatic nebulizers with Trilogy Evo Platform ven |
| Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026Using non-pneumatic nebulizers with Trilogy Evo Platform ven |
| Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026In some situations, the Obstruction Alarm does not trigger w |
| Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026In some situations, the Obstruction Alarm does not trigger w |
| Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026Using non-pneumatic nebulizers with Trilogy Evo Platform ven |
| Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026In some situations, the Obstruction Alarm does not trigger w |
| Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Class IMar 2, 2026Using non-pneumatic nebulizers with Trilogy Evo Platform ven |
| SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for thClass IIOct 7, 2025Certain serial numbers of the SimplyGo Mini standard battery |
| DreamStation Auto. Non-Continuous Ventilator.Class IJun 30, 2025Devices may possess a programming error resulting in an inco |
| DreamStation Auto CPAP. Non-Continuous Ventilator.Class IJun 30, 2025Devices may possess a programming error resulting in an inco |
| DreamStation Auto BiPAP. Non-Continuous Ventilator.Class IJun 30, 2025Devices may possess a programming error resulting in an inco |
| BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighinClass IMay 9, 2025This device does not indicate for use in patients with respi |
| BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric paClass IMay 9, 2025This device does not indicate for use in patients with respi |
| BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing moreClass IMay 9, 2025This device does not indicate for use in patients with respi |
| Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110Class IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatClass IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patClass IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult paClass IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult Class IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100Class IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200Class IOct 7, 2024Potential for in-line nebulizer configuration in certain loc |
| Trilogy Evo Universal Ventilator, Model No. DS2000X11BClass IJul 16, 2024Firm has released a mandatory software update Version 1.05.1 |
| Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy EClass IJul 16, 2024Firm has released a mandatory software update Version 1.05.1 |
| Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2Class IJul 16, 2024Firm has released a mandatory software update Version 1.05.1 |
| OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111Class IApr 1, 2024Device may experience an interruption or loss of therapy in |
| BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111Class IMar 26, 2024Potential for devices to experience interruption/loss of the |
| BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11Class IMar 26, 2024Potential for devices to experience interruption/loss of the |
| BiPAP V30 Auto Ventilator, Part Number 1111178Class IMar 26, 2024Potential for devices to experience interruption/loss of the |
| LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)Class IMar 19, 2024Potential for sudden loss of ventilation due to Battery Depl |
| Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B Class IINov 27, 2023The following was missing from the Contraindications Stateme |
| Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) Class IAug 25, 2023Power Management PCBAs may malfunction, causing a power fail |
| Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for UseClass IIMay 25, 2023There are errors present in the Korean Instructions For Use |
| Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FClass IMay 1, 2023Environmental debris may accumulate on the internal machine |
| Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110Class IMay 1, 2023Environmental debris may accumulate on the internal machine |
| Trilogy Evo Universal Ventilator, Model Number DS2000X11BClass IMay 1, 2023The Trilogy Evo Universal ventilator provides continuous or |
| Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, Class IMay 1, 2023Environmental debris may accumulate on the internal machine |
| Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15Class IMar 1, 2023The accuracy of delivered oxygen may deviate below the requi |
| Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BRClass IMar 1, 2023The accuracy of delivered oxygen may deviate below the requi |
| Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11BClass IMar 1, 2023The accuracy of delivered oxygen may deviate below the requi |
| Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UClass IFeb 10, 2023A limited number of remediated Philips DreamStation units ma |
| Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, Class IDec 7, 2022The replacement silicone sound abatement foam installed into |
| Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10Class IDec 7, 2022The replacement silicone sound abatement foam installed into |
| Philips Garbin Ventilator, Model Number 1058180BClass IDec 7, 2022The replacement silicone sound abatement foam installed into |
| Philips Respironics Amara View Minimal Contact Full-Face MaskClass ISep 6, 2022No contraindication/warning regarding magnetic components in |
| Wisp and Wisp Youth Nasal MaskClass ISep 6, 2022No contraindication/warning regarding magnetic components in |
| DreamWisp Nasal Mask with Over the Nose CushionClass ISep 6, 2022No contraindication/warning regarding magnetic components in |
| Therapy Mask 3100 NC/SPClass ISep 6, 2022No contraindication/warning regarding magnetic components in |
| Philips Respironics DreamWear Full Face MaskClass ISep 6, 2022No contraindication/warning regarding magnetic components in |
| Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndroClass IAug 26, 2022Motor assemblies manufactured with nonconforming plastic tha |
| Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea sClass IAug 26, 2022Motor assemblies manufactured with nonconforming plastic tha |
| Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstruClass IAug 26, 2022Motor assemblies manufactured with nonconforming plastic tha |
| Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patientClass IAug 26, 2022Motor assemblies manufactured with nonconforming plastic tha |
| Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndroClass IAug 26, 2022Motor assemblies manufactured with nonconforming plastic tha |
| Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apneClass IAug 26, 2022Motor assemblies manufactured with nonconforming plastic tha |
| Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides Class IDec 22, 2021Philips has identified a specific lot of non-conforming mate |
| Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous Class IDec 22, 2021Philips has identified a specific lot of non-conforming mate |
| Trilogy Evo Universal, Product number DS2000X11BClass IIJul 26, 2021Two software issues have been identified related to pressure |
| Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA21Class IIJul 26, 2021Two software issues have been identified related to pressure |
| Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110XClass IIJul 26, 2021Two software issues have been identified related to pressure |
| Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15BClass IIJul 26, 2021Two software issues have been identified related to pressure |
| A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory SuppoClass IJun 14, 2021The polyester-based polyurethane (PE-PUR) foam may degrade i |
| DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ ContinClass IJun 14, 2021The polyester-based polyurethane (PE-PUR) foam may degrade i |
| SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators Class IJun 14, 2021The polyester-based polyurethane (PE-PUR) foam may degrade i |
| Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product NumbeClass IJun 14, 2021The polyester-based polyurethane (PE-PUR) foam may degrade i |
| A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life SupportingClass IJun 14, 2021The polyester-based polyurethane (PE-PUR) foam may degrade i |
| Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.Class IJun 14, 2021The polyester-based polyurethane (PE-PUR) foam may degrade i |
| BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177Class IIApr 6, 2021Certain devices were built with motor assemblies that could |
| BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178Class IIApr 6, 2021Certain devices were built with motor assemblies that could |
| BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177Class IIApr 6, 2021Certain devices were built with motor assemblies that could |
| BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169Class IIApr 6, 2021Certain devices were built with motor assemblies that could |
| BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143Class IIApr 6, 2021Certain devices were built with motor assemblies that could |
| BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169Class IIApr 6, 2021Certain devices were built with motor assemblies that could |