Philips Respironics V60 Plus Ventilator software defect reduces oxygen delivery to patients

Plain-English summary

Philips is recalling Respironics V60 Plus Ventilators with software versions 3.00 and 3.10. These devices are assist ventilators intended to augment breathing in patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in hospital and institutional settings. A total of 23,115 systems have been distributed worldwide.

The ventilators include a High Flow Therapy safety mechanism designed to limit the maximum pressure delivered to patients. However, when system pressure reaches the maximum threshold and triggers a "Cannot Reach Target Flow" alarm, the ventilator reduces both the pressure and the flow rate below what the clinician has set. If the underlying cause of the pressure increase is not resolved, the ventilator continues delivering the lower flow rate, which can result in patients experiencing oxygen desaturation characterized as moderate or severe hypoxemia.

Clinicians and healthcare providers should be aware of this potential malfunction and monitor patients using affected ventilators for signs of inadequate oxygen saturation.

The recalled product

Product

Philips Respironics V60 Plus 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

Manufacturer

Respironics California, LLC

Category

Medical Device — Ventilator

Hazard

• hypoxemia
• oxygen-desaturation
• software-defect
• inadequate-flow

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

Related recalls