Recalls

Overview

Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm

Recall Information

FDA

The Philips Respironics V60 and V60 Plus ventilators are intended to support patient breathing. They are used to provide mechanical ventilation for adults and children who can breathe on their own, for example those with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea. The ventilators are used in hospitals or other institutional settings under the direction of health care professionals.

Philips Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts that were put together using an expired adhesive. If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.

If ventilation stops and sounds an alarm, patients could be without ventilation support for the duration required for an alternate ventilator to be connected. If the ventilator does not sound an alarm when the ventilation stops, the patient could be deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.

There have been no reports of injuries, adverse health consequences, or death associated with the use of these devices.

For more information, please visit: https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-v60-and-v60-plus-ventilators-expired-adhesive-may-cause?utm_medium=email&utm_source=govdelivery