Philips Garbin EVO Ventilator False Battery Alarm Causes Ventilation Loss
Philips Respironics recalls 1,233 Garbin EVO ventilators. A software defect in the battery and power alarm system may cause sudden loss of ventilation despite adequate power supply.
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 classification indicates the most serious type of recall. Although no illnesses or deaths are reported in the source, the potential for sudden loss of ventilation on a life-critical device represents a serious patient safety hazard that could result in severe injury or death.
Plain-English summary
Philips Respironics, Inc. is recalling Garbin EVO ventilators designed for use in pediatric and adult patients. The recall affects all software versions of the device except version 1.05.06.00, with 1,233 units identified as affected.
The recalled units have a software defect affecting the battery and power management alarm system. Under certain conditions, the Battery Depleted or Loss of Power alarm may trigger while the unit actually has sufficient power available. This malfunction creates a potential for sudden loss of ventilation.
The affected ventilators have been distributed domestically across the United States and to numerous international locations. The recalled devices can be identified by model number LD2110X23B.
Healthcare providers in possession of affected devices should verify their units against the manufacturer's information and follow Philips Respironics guidance regarding this defect.
The recalled product
- Product
- Garbin 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
- Hazard
- loss-of-ventilation
- battery-alarm-malfunction
- software-defect
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. LD2110X23B
- UDI-DI: 606959057432
- Serial No. H252356907DD7
- H2612106781C2
- H261387955F3A
- H261571963219
- H2619203865AC
- H27144085F2DA
- H2981485410EF
- H29814870657B
- H299104069E21
- H2991072461E7
- H2991911756AE
- H29924135D04F
- H299272315CC2
- H2993291565E3
- H2993303190D2
- H29936459457C
- H299366416554
- H31909781664E
Distribution
Distributed nationwide across the United States.
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