FDA today announced today another serious recall involving Royal Philips (NYSE:PHG) respiratory devices.
The recall — which Philips Respironics announced in an “Urgent Field Safety Notice” letter on June 18 — involves thousands of V60 Plus ventilators and all V60 ventilators upgraded to enable high flow therapy (software version 3.00 and 3.10). If the oxygen flow is partially blocked for any reason, the system will go on providing the patient with lower oxygen flow rate — issuing a low priority alarm.
FDA said there had been reports of 61 incidents, 25 injuries and no deaths related to the problem. (More information is available on FDA’s website.)
Philips’ letter to customers included instructions such as constant monitoring of patients and urgent response to alarms regardless of their priority. Philips distributed the ventilators involved in the recall from May 1, 2009, to June 2, 2021.
About two weeks ago, FDA issued two other Class I designations involving Philips’s recall of millions of sleep therapy systems. Days later, during a July 26 earnings call, Philips CEO Frans van Houten said the company was no longer taking orders of sleep therapy systems as it focused on addressing problems.
Van Houten said it would take 12 months after regulatory approval to address problems with all the devices, which have a polyester-based polyurethane (PE-PUR) sound abatement foam that could potentially break down and enter a device’s air pathway. There have been more than 1,200 complaints and more than 100 injuries, according to FDA.
Analysts have noted that the situation could be an opportunity for competitor ResMed.
