Respironics, Inc
FDA adverse event reports naming Respironics, Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: RESPIRONICS, INC.
- Total reports
- 28,902
- Deaths
- 100
- Injuries
- 793
- Malfunctions
- 27,984
Reports per year
Source: FDA adverse event reports by year received, 2010–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK16,009
- Ventilator, Non-Continuous (Respirator)BZD12,529
- Ventilator, Continuous, Non-Life-SupportingMNS341
- Generator, Oxygen, PortableCAW10
- Ventilator, Emergency, Manual (Resuscitator)BTM3
- Sv70 VentilatorMNT3
- Infant Heel Warmer (Chemical Heat Pack)MPO3
- Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2
- Product code ------1
- Nebulizer (Direct Patient Interface)CAF1
Recent recalls
- 2026-04-02Open, ClassifiedSoftware design
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.
- 2026-04-02Open, ClassifiedSoftware design
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.
- 2026-04-02Open, ClassifiedSoftware design
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.
- 2026-04-02Open, ClassifiedSoftware design
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.
- 2026-03-26Open, ClassifiedUnder Investigation by firm
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.
- 2026-03-26Open, ClassifiedUnder Investigation by firm
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.
- 2026-03-26Open, ClassifiedUnder Investigation by firm
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.
- 2026-03-26Open, ClassifiedUnder Investigation by firm
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.
- 2025-11-07Open, ClassifiedNonconforming Material/Component
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: 1113600
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.
- 2025-08-08Open, ClassifiedProcess control
DreamStation Auto CPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
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