Philips Respironics recalls
22 official recalls and safety alerts involving Philips Respironics since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Philips Respironics or the relevant agency.
- 2026-04-08
USPhilips Respironics, Inc. recalls 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.
FDA · DevicePhilips Respironics, Inc.Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia…Official notice →- 2026-04-01
- US
Philips Respironics, Inc. recalls 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.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of:…Official notice → - 2025-11-19
- US
Philips Respironics, Inc. recalls SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini:…
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…
FDA · DevicePhilips Respironics, Inc.US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country…Official notice → - 2025-08-20
- US
Philips Respironics, Inc. recalls DreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
FDA · DevicePhilips Respironics, Inc.Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE,…Official notice → - 2025-07-09
- US
Philips Respironics, Inc. recalls BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP…
This device does not indicate for use in patients with respiratory failure.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS…Official notice → - 2024-11-20
- US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through…
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.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT,…Official notice → - 2024-09-11
- US
Philips Respironics, Inc. recalls Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo,…
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.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU,…Official notice → - 2024-05-29
- US
Philips Respironics, Inc. recalls OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127…
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…
FDA · DevicePhilips Respironics, Inc.US Nationwide distribution and OUS International distribution to Canada.Official notice → - US
Philips Respironics, Inc. recalls 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…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium,…Official notice → - 2024-04-24
- US
Philips Respironics, Inc. recalls 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.
FDA · DevicePhilips Respironics, Inc.Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO,…Official notice → - 2024-01-10
- US
Philips Respironics, Inc. recalls Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B…
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…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL,…Official notice → - 2023-10-04
- US
Philips Respironics, Inc. recalls Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276…
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
FDA · DevicePhilips Respironics, Inc.US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.Official notice → - 2023-07-12
- US
Philips Respironics, Inc. recalls Trilogy 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".
- 2023-06-14
- US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model Number DS2000X11B
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…
- US
Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B,…
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…
- 2023-04-12
- US
Philips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.…
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…
- US
Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B,…
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…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including Puerto Rico, and countries of…Official notice → - 2023-01-18
- US
Philips Respironics, Inc. recalls Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B,…
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…
FDA · DevicePhilips Respironics, Inc.US Nationwide and Global Distribution to countries of: Australia, Brazil,…Official notice → - 2022-10-12
- US
Philips Respironics, Inc. recalls Wisp and Wisp Youth Nasal Mask
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2022-09-14
- US
Philips Respironics, Inc. recalls Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and…
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
FDA · DevicePhilips Respironics, Inc.Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2022-03-30
- US
Philips Respironics, Inc. recalls Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home,…
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018…
- 2022-02-02
- US
Philips Respironics, Inc. recalls Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent…
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming…
FDA · DevicePhilips Respironics, Inc.Worldwide Distribution: Distributed to the following US states: AR, CO, FL,…Official notice →