Philips has received authorization from the US Food and Drug Administration (FDA) to begin the repair and/or replacement process for affected first-generation DreamStation devices in the US1. The company is also initiating repair and/or replacement programs in other countries and expects to have these underway in the majority of its markets by the end of September 2021. Philips intends to complete the repair and replacement programs within approximately 12 months.
In August, the company started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. The addition of this first-generation DreamStation repair and/or replacement process enables Philips to begin replacing affected DreamStation devices on a larger scale. Philips remains in dialogue with the FDA on other aspects of the recall notification and mitigation plan in the US2.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” said 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.”
For more information on the recall notification*, as well as instructions for customers, users, and physicians, visit www.philips.com/src-update. Patients with affected devices are requested to register their products on this website to facilitate their replacement.