Royal Philips’ subsidiary Philips Respironics has issued a voluntary recall notification/field safety notice to customers of its V60/V60 Plus and V680 ventilators.
The company has notified its customers regarding a potential issue with the electrical circuit that controls the 35V power supply to the ventilator and alarm.
The relevant competent authorities have already been informed regarding the issue.
Philips Respironics has identified that there is a chance that the affected ventilators may stop working without giving an audible/visual alarm, meaning the patient may not receive respiratory support.
Customers are being advised to implement measures to prevent the rare chance of the danger caused by the 35V electric circuit issue.
The company is advising users to implement an oxygen analyser with appropriate alarm settings and to also monitor patients with pulse oximetry or other physiological monitoring.
It is also suggested to connect the V60/V60 Plus and V680 ventilators to a nurse call/remote alarm system, as documented in the instructions for use.
Philips Respironics noted that it can provide technical assistance for implementing the nurse call/remote alarm capability upon request.
It also recommends that institutions make a decision that can balance the risks and advantages of continued usage of the ventilators against the risks and benefits of ceasing use and/or substituting other ventilators if the mitigation measures are not available.
Philips Respironics business leader David Ferguson said: “We are committed to providing products and solutions that are safe and reliable for those who depend on them.
“The V60 ventilator has been in service for more than ten 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.”
Furthermore, the company stated that it will provide consumers with regular updates from 30 June regarding the development of its plan to address the issue.