Philips issues voluntary recall for V60 vents
By HME News Staff
Updated 10:26 AM CDT, Mon April 25, 2022
AMSTERDAM, the Netherlands – Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit that controls the 35V power supply to the ventilator and alarm.
The company has identified that there is a possibility that effected vents may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown) and the patient may no longer receive respiratory assistance. It is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue:
- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus or V680, and /or
- Connect the V60/V60 Plus or V680 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 capability), and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.
“We are committed to providing products and solutions that are safe and reliable for those who depend on them,” said David Ferguson, business leader of Philips Respironics. “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.”
Additionally, Philips Respironics says if a fault is detected, the patient should be disconnected from the unit and immediately started on ventilation with an alternative.
The company projects an average of one silent shutdown among 1 million uses per year.
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