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.
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…
Nov. 20, 2024Trilogy Evo O2… and 6 more productsClass IPotential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor…
May 29, 2024BiPAP V30 Auto Ventilator… and 2 more productsClass IPotential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to…
April 24, 2024Aeris EVO… and 6 more productsClass IPotential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
July 12, 2023Trilogy Evo…Class IIThere are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
June 14, 2023Trilogy Evo… and 3 more productsClass IEnvironmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure…
April 12, 2023Philips DreamStation Auto BiPAP and CPAP…Class IA limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management…
Jan. 18, 2023Philips Trilogy 100 Ventilator… and 2 more productsClass IThe replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which…
Sept. 14, 2022Philips BiPAP A30… and 5 more productsClass IMotor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
March 30, 2022Trilogy 100…Class IIn 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based…
Feb. 2, 2022Trilogy Evo… and 1 more productClass IPhilips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used…
Aug. 25, 2021Trilogy Evo… and 3 more productsClass IITwo software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS…
July 21, 2021Trilogy 100… and 2 more productsClass IThe polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the…
June 2, 2021BiPAP V30 Auto… and 5 more productsClass IICertain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing…
Feb. 26, 2020Trilogy EVO Ventilator… and 12 more productsClass ISoftware 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…
How we match: a recall is listed here when the agency names Philips Respironics as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.
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