Sam Brusco, Associate Editor04.25.22
Philips Respironics has recalled its V60/V60 Plus, and V680 ventilators over a potential issue with their electrical circuit that controls the 35V volt power supply to the ventilator and alarm. The U.S. Food and Drug Administration (FDA) classified the recall as Class 1.
The affected units may cease to operate, potentially without setting off an audible/visual alarm and the patient may no longer receive respiratory assistance as a result. Philips expects an average of less than one “silent shutdown” among a million annual uses.
Philips advised customers to implement one or more of the following actions:
An alternative means of ventilation should be available when the affected ventilators are in use. If mitigations aren’t available, customers are advised to make a decision balancing risks and benefits of continuing to use the affected ventilators over ceasing use/substituting other ventilators.
“We are committed to providing products and solutions that are safe and reliable for those who depend on them,” David Ferguson, Business Leader of Philips Respironics told the press. “The V60 ventilator has been in service for more than 10 years with a high record of reliability. We take every customer complaint seriously, and whenever we identify an issue, we address it thoroughly and transparently in consultation with the relevant competent authorities. We have created a dedicated team that is focused on addressing the current issue and providing technical assistance where needed.”
The affected units may cease to operate, potentially without setting off an audible/visual alarm and the patient may no longer receive respiratory assistance as a result. Philips expects an average of less than one “silent shutdown” among a million annual uses.
Philips advised customers to implement one or more of the following actions:
- Use an oxygen analyzer with appropriate alarm settings for each unit.
- Connect the ventilators to a nurse/remote alarm system.
- Monitor patients with pulse oximetry or other physiological monitoring.
An alternative means of ventilation should be available when the affected ventilators are in use. If mitigations aren’t available, customers are advised to make a decision balancing risks and benefits of continuing to use the affected ventilators over ceasing use/substituting other ventilators.
“We are committed to providing products and solutions that are safe and reliable for those who depend on them,” David Ferguson, Business Leader of Philips Respironics told the press. “The V60 ventilator has been in service for more than 10 years with a high record of reliability. We take every customer complaint seriously, and whenever we identify an issue, we address it thoroughly and transparently in consultation with the relevant competent authorities. We have created a dedicated team that is focused on addressing the current issue and providing technical assistance where needed.”