On Sept. 1, Philips announced that it has received authorization from the Food and Drug Administration to “rework” the recalled first-generation DreamStation devices by replacing the sound abatement foam with a new material. Philips anticipates that the repair program will begin this month.
The company also confirmed that it already has begun replacing certain recalled devices with DreamStation 2 devices, which have a different, silicone-based foam that is not included in the recall. Philips indicates that it intends to complete the repair and replacement programs within approximately 12 months.
For more information, contact Philips at (877) 907-7508.
Other Recent Updates
- Philips supplemental clinical information for the use of bacteria filters– August
- FDA frequently asked questions: Philips Respironics CPAP, BiPAP, and ventilator recall – July 29
- DME MACs: Frequently asked questions – Philips Respironics respiratory products recall – July 16
View the AASM guidance in response to the Philips recall of PAP devices.
