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FDA Puts Highest-Risk Label on Ventilators

Posted on in Defective Medical Devices

Respironics, a subsidiary of Phillips, has recently received the FDA's highest-risk label for a recall that has affected over 19,000 V60 ventilators. These ventilators were pulled due to potentially dangerous power management software.

These V60 ventilators are used to aid with breathing in the hospital or at home for those patients who face “respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea.” The devices got the Class 1 status recall due to a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

California-based Respironics originally recalled its V60 ventilators when they discovered a major issue with their power management software. The devices were often shutting down suddenly, which ends the flow of ventilator support to a patient, without sounding any sort of alarm.

According to a company statement, Respironics initiated their recall back in the beginning of June and was notified of the FDA's highest-risk label on June 17. The device manufacturers have stated that they have already developed a solution to the problem and have issued a warning to all distributors, providers, sales personnel, and customers who may need the newly updated software.

Medical devices are recalled all the time. If you or somebody you know has faced negative consequences after using a defective medical device, don't hesitate to contact an Illinois defective medical device attorney. In many cases, those who have faced injury or loss due to defective devices are eligible for compensation. Contact an experienced attorney to assist you.

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