Philips Respironics, Inc. Recalls

37 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (37)

March 2, 2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class I
March 2, 2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Class I
March 2, 2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Class I
March 2, 2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class I
March 2, 2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Class I
March 2, 2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Class I
March 2, 2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class I
March 2, 2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Class I
October 7, 2025
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
Class II
June 30, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
Class I
June 30, 2025
DreamStation Auto. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
Class I
June 30, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
Class I
May 9, 2025
BiPAP 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.
Class I
May 9, 2025
BiPAP 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.
Class I
May 9, 2025
BiPAP 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 ventilat
This device does not indicate for use in patients with respiratory failure.
Class I
October 7, 2024
LifeVent 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 tran
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.
Class I
October 7, 2024
Trilogy 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
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.
Class I
October 7, 2024
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB
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.
Class I
October 7, 2024
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN
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.
Class I
October 7, 2024
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR
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.
Class I
October 7, 2024
Aeris 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 transpo
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.
Class I
October 7, 2024
Garbin 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 transp
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.
Class I
July 16, 2024
Trilogy 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 Tri
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.
Class I
July 16, 2024
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy
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.
Class I
July 16, 2024
Trilogy 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.
Class I
April 1, 2024
OmniLab 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.
Class I
March 26, 2024
BiPAP 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.
Class I
March 26, 2024
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R11111
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.
Class I
March 26, 2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR11111
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.
Class I
March 19, 2024
Trilogy 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.
Class I
March 19, 2024
Garbin 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.
Class I
March 19, 2024
Trilogy 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.
Class I
March 19, 2024
Trilogy 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.
Class I
March 19, 2024
LifeVentEVO2, 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.
Class I
March 19, 2024
Aeris 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.
Class I
March 19, 2024
Trilogy 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.
Class I
November 27, 2023
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X
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.
Class II

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