Philips Respironics, Inc.
38 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips Respironics, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-20FDA-DeviceClass IDreamStation Auto. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-08-20FDA-DeviceClass IDreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-08-20FDA-DeviceClass IDreamStation Auto CPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-07-09FDA-DeviceClass IBiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
This device does not indicate for use in patients with respiratory failure.
- 2025-07-09FDA-DeviceClass IBiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
This device does not indicate for use in patients with respiratory failure.
- 2025-07-09FDA-DeviceClass IBiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
This device does not indicate for use in patients with respiratory failure.
- 2024-11-20FDA-DeviceClass ILifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DeviceClass IGarbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DeviceClass IAeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DeviceClass ITrilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DeviceClass ITrilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DeviceClass ITrilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport setti
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-11-20FDA-DeviceClass ITrilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- 2024-09-11FDA-DeviceClass ITrilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- 2024-09-11FDA-DeviceClass ITrilogy Evo Universal Ventilator, Model No. DS2000X11B
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- 2024-09-11FDA-DeviceClass ITrilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Tril
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- 2024-05-29FDA-DeviceClass IOmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
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.
- 2024-05-29FDA-DeviceClass IBiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- 2024-05-29FDA-DeviceClass IBiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Num
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- 2024-05-29FDA-DeviceClass IBiPAP V30 Auto Ventilator, Part Number 1111178
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- 2024-04-24FDA-DeviceClass ITrilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceClass ITrilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceClass ITrilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceClass ITrilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceClass ILifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceClass IGarbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceClass IAeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-01-10FDA-DeviceClass IITrilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
- 2023-10-04FDA-DeviceClass IPhilips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
- 2023-07-12FDA-DeviceClass IITrilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
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