Philips Trilogy EV300 Ventilator False Power Alarm Defect Recall
Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall with serious potential for sudden loss of ventilation in dependent patients. No illnesses or deaths are reported in the source, preventing classification as Critical, but the Class I designation and life-threatening nature of the defect establish Severe as the appropriate level.
Plain-English summary
Philips Respironics, Inc. is recalling approximately 56,012 units of the Trilogy EV300 ventilator (all software versions except 1.05.06.00), a device used for pediatric and adult patients requiring mechanical ventilation.
The recalled ventilators contain a software defect that can trigger a Battery Depleted or Loss of Power alarm when the unit actually has sufficient power available. This false alarm could cause sudden loss of ventilation, creating a critical emergency for patients dependent on the device for respiratory support.
The affected ventilators were distributed throughout the United States and internationally across more than 60 countries. This is an FDA Class I recall, the agency's highest classification, indicating serious potential for patient harm.
The recalled product
- Product
- Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 56,012
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. BL2200X15B
- BR2200X18B
- CA2200X12B
- EE2200X15B
- EU2100X15B
- EU2100X19
- EU2200X15B
- FR2200X14B
- DE2200X13B
- GB2200X15B
- FX2100X15B
- FX2200X15B
- IN2100X15B
- IN2100X19
- IN2200X15B
- IT2200X21B
- JP2100X16B
- KR2200X15B
- LA2100X15B
- ND2200X15B
Distribution
Part of a larger recall action
This product is one of 7 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Philips Respironics, Inc.
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FDA (Devices) · 2026-04-08
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- SevereTrilogy Evo obstruction alarm may take up to four breaths
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- SevereTrilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · loss of ventilation
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- SeverePhilips Respironics Aeris EVO Ventilators Recalled for Loss of Ventilation Risk
FDA (Devices) · 2024-04-24
- SeverePhilips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm
FDA (Devices) · 2024-04-24
- SeverePhilips Garbin EVO Ventilator False Battery Alarm Causes Ventilation Loss
FDA (Devices) · 2024-04-24