LifeVentEVO2 Ventilator Recalled for Potential Loss of Ventilation
Philips Respironics is recalling the LifeVentEVO2 ventilator due to a software malfunction that can trigger a false Battery Depleted or Loss of Power alarm when power is sufficient, potentially causing 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 for a life-critical medical device (ventilator for pediatric and adult patients). The hazard—sudden loss of ventilation due to a false alarm—poses a serious risk to dependent patients. Although no deaths or reported hospitalizations are mentioned in the notice, the Class I classification and the critical nature of the affected device warrant a Severe severity rating.
Plain-English summary
Philips Respironics, Inc. is recalling all versions of the LifeVentEVO2 ventilator except software version 1.05.06.00 due to a critical safety issue involving a false power alarm. The device can display a Battery Depleted or Loss of Power alarm even when the ventilator has sufficient power available.
This false alarm can result in a sudden loss of ventilation, which poses a serious risk to pediatric and adult patients dependent on the device for life support. The issue affects approximately 1,002 units distributed across the United States and over 80 countries internationally.
Patients and healthcare providers using the LifeVentEVO2 ventilator should contact Philips Respironics or their healthcare provider immediately for guidance. Facilities should verify their device software version and update to version 1.05.06.00 if necessary to avoid this malfunction.
The recalled product
- Product
- LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- ventilation-loss
- false-alarm
- software-malfunction
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. SP2100X26B
- UDI-DI: 606959057456
- Serial No. H25691987749F
- H25693118A4C4
- H26260563C38D
- H272315740BD0
- H275461032A2A
- H2754619843E1
- H800113616C69
- H8001868315B5
- H80018684610A
- H800186864218
- H25960483860A
- H25961937C742
- H259841474367
- H260431913B25
- H262335860DA9
- H262602020AD1
- H262644950D43
- H262646266EC8
Distribution
Distributed nationwide across the United States.
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