Royal Philips (NYSE:PHG) announced today that it initiated repair and replacement programs for its recalled sleep therapy devices.
Amsterdam-based Philips in June issued an urgent medical device recall for its DreamStation continuous positive airway pressure (CPAP) devices, with the FDA classifying the recall as Class I, the most serious kind, in July. The recall has spurred both legal action and congressional scrutiny over recent weeks.
The company confirmed in that month that it is no longer taking orders of sleep therapy systems as it handles the recall, which may knock it out of the sleep therapy market for a year. As a result of the recall, ResMed saw a dramatic surge in demand for its sleep and respiratory care products and is now facing supply chain issues.
More than half the affected DreamStation devices in use globally are in the U.S. Philips said in a news release that it received FDA authorization for the rework of the affected first-generation DreamStation devices, which it expects to commence sometime this month. Additionally, the company has already begun to replace certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices.
Repair and replacement programs in other countries are also being initiated by Philips, which expects to have them underway in the majority of its markets by the end of this month and plans to complete the programs within about one year.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” Philips CEO Frans van Houten said in the release. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”