88 club

88 club starts repair and/or replacement program of first-generation DreamStation devices in the US and other markets

88 club 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. 88 club 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 88 club to begin replacing affected DreamStation devices on a larger scale. 88 club 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 88 club. “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 . Patients with affected devices are requested to register their products on this website to facilitate their replacement.