Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 mandates a minimum severity score of 4. A ventilator with potential measurement inaccuracies in critical respiratory care settings poses serious patient safety risks, though no specific injuries are reported in this notice.
Plain-English summary
Philips Respironics, Inc. is recalling the Aeris EVO Model VT2110X24B ventilator. A total of 804 units have been distributed worldwide.
The recall stems from a potential configuration issue involving the in-line nebulizer. Under certain conditions, aerosol deposits may accumulate on the device's internal flow sensor, potentially leading to inaccurate flow measurements. These inaccuracies could affect the precision of ventilation delivery to patients.
The Aeris EVO is used 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. The affected product is Model VT2110X24B with all serial numbers included in the recall.
Information regarding this recall is available from the FDA and Philips Respironics, Inc.
The recalled product
- Product
- Aeris EVO. Model Number: VT2110X24B. 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
- Affected units
- 804
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 (2)
- Model Number: VT2110X24B
- UDI-DI Number: 606959062962. All Serial Numbers.
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.
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