Philips Respironics, Inc. recalls
27 recalls in our records from 2016 to 2026: 27 FDA medical devices.
Recalls with full detail pages
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Philips Respironics, Inc. medical device recall: Philips Respironics Trilogy Evo
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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Philips Respironics, Inc. medical device recall: Philips Respironics Trilogy Evo
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…
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Philips Respironics, Inc. medical device recall: DreamStation Auto CPAP. Non-Continuous Ventilator
Devices may possess a programming error resulting in an incorrect device configuration.
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Philips Respironics, Inc. medical device recall: BiPAP V30 Auto Ventilator. Intended to provide non-invasive…
This device does not indicate for use in patients with respiratory failure.
Earlier and other recalls
These link to the official agency notice.
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Philips Respironics, Inc. medical device recall: SimplyGo Mini Official notice ↗
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…
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Philips Respironics, Inc. medical device recall: Trilogy Evo O2. Model Numbers: FP2100X10 Official notice ↗
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…
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Philips Respironics, Inc. medical device recall: Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B… Official notice ↗
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…
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Philips Respironics, Inc. medical device recall: OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124… Official notice ↗
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,…
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Philips Respironics, Inc. medical device recall: BiPAP V30 Auto Ventilator Official notice ↗
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia,…
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Philips Respironics, Inc. medical device recall: Aeris EVO Official notice ↗
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
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Philips Respironics, Inc. medical device recall: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B… Official notice ↗
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…
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Philips Respironics, Inc. medical device recall: Philips Respironics V60/V60 Plus Ventilator Official notice ↗
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
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Philips Respironics, Inc. medical device recall: Trilogy Evo Official notice ↗
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
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Philips Respironics, Inc. medical device recall: Trilogy Evo Official notice ↗
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A…
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Philips Respironics, Inc. medical device recall: Philips DreamStation Auto BiPAP and CPAP Official notice ↗
A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this…
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Philips Respironics, Inc. medical device recall: Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator Official notice ↗
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if…
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Philips Respironics, Inc. medical device recall: Philips Trilogy 100 Ventilator Official notice ↗
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…
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Philips Respironics, Inc. medical device recall: Philips Respironics Amara View Minimal Contact Full-Face Mask Official notice ↗
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
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Philips Respironics, Inc. medical device recall: Philips BiPAP A30 Official notice ↗
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
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Philips Respironics, Inc. medical device recall: Trilogy 100 Official notice ↗
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR)…
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Philips Respironics, Inc. medical device recall: Trilogy Evo Official notice ↗
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane…
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Philips Respironics, Inc. medical device recall: Trilogy Evo Official notice ↗
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase"…
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Philips Respironics, Inc. medical device recall: Trilogy 100 Official notice ↗
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR…
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Philips Respironics, Inc. medical device recall: Philips Respironics E30 with Humidifier Official notice ↗
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the…
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Philips Respironics, Inc. medical device recall: BiPAP V30 Auto Official notice ↗
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic…
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Philips Respironics, Inc. medical device recall: Trilogy EVO Ventilator Official notice ↗
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and…
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Philips Respironics medical device recall: Trilogy 100 Official notice ↗
Software Issue
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.