Philips Respironics V60 Ventilator Flow Rate Reduction Safety Defect
Philips Respironics V60 ventilators with High Flow Therapy software versions 3.00 and 3.10 may reduce oxygen delivery below prescribed levels when pressure limits are reached, risking oxygen desaturation.
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 mandates a minimum severity score of 4 per the classification rules. The defect creates a risk of oxygen desaturation and hypoxemia in ventilator-dependent patients, though no injuries or deaths are reported in the source material.
Plain-English summary
Philips Respironics V60 ventilators equipped with High Flow Therapy (software versions 3.00 and 3.10) are subject to this FDA Class I recall. The devices are intended to augment breathing in spontaneously breathing individuals requiring mechanical ventilation in hospital and institutional settings.
The ventilators contain a designed safety mechanism that limits maximum pressure delivery to patients. When system pressure reaches this limit and triggers a "Cannot Reach Target Flow" alarm, the ventilator reduces both pressure and flow rate below the level set by clinicians. If the underlying pressure issue persists, the ventilator continues delivering the lower flow rate rather than alerting clinicians to the problem.
This defect can result in patients experiencing oxygen desaturation, characterized as moderate or severe hypoxemia, potentially putting ventilator-dependent patients at risk.
Approximately 23,115 V60/V60 Plus systems have been distributed worldwide. Clinicians and healthcare facilities using these devices should review the recall details and consult manufacturer guidance for corrective action or firmware updates.
The recalled product
- Product
- Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: pat
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Hazard
- hypoxemia
- oxygen-desaturation
- flow-rate-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 (8)
- Model V60 Ventilator: P/N 1053613
- 1053614
- 1053615
- 1053616
- 1053617
- DU1053617
- U1053617
- 1076716
Distribution
Distributed nationwide across the United States.
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