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-generatio…