Philips Respironics, a subsidiary of Royal Philips, has issued a voluntary recall notification/field safety notice for the V60/V60 Plus and V680 ventilators product range.
Philips Respironics has notified about a potential issue with the electric circuit in V60/V60 Plus and V680 ventilators that controls the 35V power supply to the ventilator and alarm.
According to the company, there is a chance that affected ventilators devices will stop working without causing an audible/visual alert, and the patient will no longer get respiratory support.
Philips Respironics has anticipated less than one silent shutdown per million usages each year. It has already informed the relevant competent authorities.
The company has issued multiple mitigations to cross-check the possibility of an issue caused by the electric circuit.
Customers are advised by the company to implement mitigation measures to prevent the uncommon chance of a danger caused by the 35V electric circuit issue.
Philips is recommending that users connect the ventilators to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability.
Furthermore, the company is suggesting customers implement an oxygen analyser with appropriate alarm settings and monitor the patient with pulse oximetry.
If the mitigation measures are not accessible, Philips Respironics suggested that each institution carefully weigh the risks and advantages of continuing to use ventilators against the risks and benefits of discontinuing usage and/or replacing other ventilators.
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 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.”
Philips Respironics said that it is committed to addressing the issue and will offer consumers with regular updates, starting from 30 June 2022, on the development of its strategy to tackle the issue.
In April 2020, Philips Respironics introduced the Respironics E30 ventilator for emergency use with visual and audible alarms for Covid-19 patients.
