Royal Philips announced an update in connection with the 14 June 2021 recall notification* for specific Philips sleep and respiratory care devices 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 US. The vast majority (>80%) of the registered affected devices in the US to date are in the first-generation DreamStation product family.
Philips received authorization from the US Food and Drug Administration (FDA) to rework the affected first-generation DreamStation devices [1], which consists of replacing the PE-PUR sound abatement foam with new material. Philips anticipates reworking to commence in September 2021.
In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US 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 US [2].
Philips to initiate repair and replacement programs in different countries
Philips is also initiating the repair and replacement programs in other countries and expects to have this underway in the majority of its markets by the end of September 2021. 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,” said Frans van Houten, chief executive officer 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 and 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.
* This is a recall notification for the US only and a field safety notice for the rest of the world. In the US, the recall notification has been classified by the FDA as a Class I recall.
[1] This includes DreamStation CPAP, Auto CPAP; Dream Station Bi-Level PAP; DreamStation ASV; and DreamStation ST, AVAPS devices.
[2] The remaining affected devices for remediation in the US can be found at www.philips.com/src-update.
