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
- Hazard
- loss-of-ventilation
- false-alarm
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
Distributed nationwide across the United States.
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