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Philips Respironics Recalls
94 recalls on record · March 16, 2016 to April 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
January 10, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B
Hazard: 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.
October 4, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US)
Hazard: Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
July 12, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Hazard: There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
June 14, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Hazard: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
June 14, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,
Hazard: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
June 14, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, F
Hazard: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
June 14, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110
Hazard: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
April 12, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U
Hazard: A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.
April 12, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Hazard: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
April 12, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR
Hazard: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
April 12, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15
Hazard: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
January 18, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Garbin Ventilator, Model Number 1058180B
Hazard: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
January 18, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800,
Hazard: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
January 18, 2023Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10
Hazard: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
October 12, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Therapy Mask 3100 NC/SP
Hazard: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
October 12, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Wisp and Wisp Youth Nasal Mask
Hazard: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
October 12, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls DreamWisp Nasal Mask with Over the Nose Cushion
Hazard: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
October 12, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics DreamWear Full Face Mask
Hazard: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
October 12, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Amara View Minimal Contact Full-Face Mask
Hazard: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
September 14, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patient
Hazard: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
September 14, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstru
Hazard: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
September 14, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apne
Hazard: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
September 14, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea s
Hazard: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
September 14, 2022Medical DevicesFDA
Philips Respironics, Inc. recalls Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro
Hazard: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.