Product News and Recalls

Philips Ventilator Recall Sees Class I Status from FDA

philips breathing machines recalledAs the delta variant of the COVID-19 pandemic sweeps through largely unvaccinated swaths of populations around the world, certain Philips ventilators and other breathing apparatuses have been pulled from service for a failure to function properly. The severity of the failure has earned the recall a Class I status from the U.S. Food and Drug Administration which is reserved only for the direst of circumstances where continued use of the product could result in serious injury or death.

Models of the V60 and V60 Plus ventilators have been recalled over concerns that they could deliver lower amounts of oxygen than what was programmed. Given the ventilator’s critical role in delivering air and oxygen to patients that are incapable of breathing on their own, the inability to trust the machine to function as prescribed is understandably incredibly troubling.

Just eight months into the year, this is now the second recall to hit Philips in 2021. The first recall was over concerns that the sound insulating foam used to quiet the machines could deteriorate and enter the breathing loop. This deterioration could send foam particles into patients’ lungs and irritate their airways. The recall affected Philips ventilators but took some of the company’s BiPAP and CPAP machines out of service as well.

Over 17,000 Philips ventilators have been recalled at a time when every ventilator in the country needs to be standing ready to help those stricken with COVID-19, as well as to serve the other critical life-saving functions that ventilators provide to the seriously ill.