Royal Philips, Amsterdam, announces an update in connection with the June 14 recall notification for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices in use globally are in the U.S. And more than 80% of the registered affected devices in the U.S., to date, are in the first-generation DreamStation product family.
Philips received authorization from the U.S. FDA for the rework of the affected first-generation DreamStation devices, which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in September. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices.
“Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the U.S.,” the company said in a statement.
Moreover, Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in most of its markets by the end of September. The company intends to complete the repair and replacement programs within approximately 12 months.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” says Frans van Houten, CEO of Royal Philips. “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.”
More information on the recall notification, as well as instructions for customers, users, and physicians can be found at www.philips.com/src-update. Patients with affected devices currently in use are requested to register their products on this website to facilitate the repair and replacement program.