Recall – Software error can lead to inadequate ventilation

Company: Respironics California, LLC
Date of Enforcement Report: 7/28/2021
Class I

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.

Recall Number: Z-2073-2021

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/MANUFACTURER

Respironics California, LLC on 6/18/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

Total of V60/V60 Plus = 23,115 systems

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

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