Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms

FDA Recall

Device Use: 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.

Reason for Recall: Philips Respironics is recalling all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. The power fluctuation causes a reboot of the backup alarm controller, which may lead to a complete shutdown of the ventilator without warning.

Affected ventilators may cease ventilation either with or without alarms. Such failures may lead to patients being deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.

As of April 14, 2022, there have been reports of 4 injuries and 1 death associated with the use of the recalled devices.

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