Philips Respironics Recalls V60/V60 Plus, V680 Ventilators
Philips Respironics, a unit of Dutch consumer electronics giant Philips Electronics NV, has recalled V60/V60 Plus and V680 ventilators in the United States due to a potential issue with the electrical circuit, the U.S. Food and Drug Administration said.
For the rest of the world, the company has issued a field safety notice for the V60 Ventilator product range.
According to the agency, the actions are due to a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm.
Philips Respironics has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm, i.e., a so-called silent shutdown, and the patient may no longer receive respiratory assistance.
The company projects an average of less than one silent shutdown among one million uses per year.
Philips Respironics has already notified the relevant competent authorities about the issues.
The affected customers are urged to implement certain actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue. They are asked to 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; and/or monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.
Regarding connecting the ventilator to a nurse call/remote alarm system, the agency noted that it can be done as documented in the instructions for use. Upon request, Philips Respironics will provide technical assistance to implement this nurse call/remote alarm capability.
The customers are also asked to make available an alternative means of ventilation whenever the V60/V60 Plus or V680 ventilator is in use.
The V60 ventilator has been in service for more than 10 years.
Philips Respironics will provide the first update regarding the issue before June 30.
Philips has already taken a provision in the fourth quarter of 2021 in connection with thes recall notification/field safety notice.
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