Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure
Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during 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: This is an FDA Class I recall, which establishes a minimum severity score of 4. No deaths or injuries have been reported; the hazard is a potential malfunction (aerosol-induced sensor fouling) that could affect measurement accuracy in a critical life-support device.
Plain-English summary
Philips Respironics, Inc. is recalling the LifeVent EVO2 ventilator, Model Number SP2100X26B. This device is intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. Approximately 1,244 units have been distributed worldwide and in the United States.
The recall addresses a potential issue where in-line nebulizer configuration in certain locations can cause aerosol deposits to accumulate on the device's internal flow sensor. This accumulation could result in inaccurate flow measurements during ventilation.
Patients and caregivers using an affected ventilator should contact Philips Respironics for further guidance. Healthcare providers should review this recall notice and determine appropriate steps for affected devices in their facilities.
The recalled product
- Product
- LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Hazard
- aerosol-accumulation
- sensor-fouling
- inaccurate-measurement
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 (3)
- Model No. SP2100X26B
- UDI-DI: 606959057456
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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