Recall Z-2073-2021— Respironics California, LLC

Class I FDA medical device recall by Respironics California, LLC, initiated 2021-06-18. FDA's recall record names no specific 510(k) clearance for this event. 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: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.. Reason: It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia..

Recalling firm

Respironics California, LLC

Classification

Class I

Status

Ongoing

Initiated

2021-06-18

Firm location

Carlsbad, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.