Philips Respironics Aeris EVO Ventilators Recalled for Loss of Ventilation Risk
Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.
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: FDA Class I medical device recall affecting a life-sustaining respiratory device. The hazard of sudden loss of ventilation creates a significant risk of serious injury to pediatric and adult patients dependent on the device, though no specific illnesses or injuries have been reported.
Plain-English summary
Philips Respironics is recalling Aeris EVO ventilators with all software versions except 1.05.06.00. These ventilators are used to provide respiratory support for pediatric and adult patients.
The recalled devices contain a software defect that may cause a false 'Battery Depleted' or 'Loss of Power' alarm to appear even when the unit has adequate power available. This defect creates a risk of sudden, unexpected loss of ventilation.
Approximately 775 affected units have been distributed in the United States and internationally. Users of Aeris EVO ventilators should contact Philips Respironics regarding their device to determine if it is affected and what corrective measures are needed.
The recalled product
- Product
- Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 775
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. VT2110X24B
- UDI-DI: 606959062962
- Serial No. H31910535835D
- H319109655846
- H31911031E07F
- H319110396C37
- H3191306384A3
- H3191532256B4
- H319155872AB0
- H3191570317EC
- H3191583620EE
- H31915891A921
- H319159299B1D
- H319160784DFF
- H3191618894EB
- H31917208A9F4
- H319172300FD4
- H3191724627EA
- H319173454FAD
- H319173602BB0
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
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