The FDA has received 270 Medical Device Reports (MDR), between August 1, 2023 & November 15, 2023
These MDRs are associated with thermal issues such as fire, smoke, burns and other signs of overheating while people are using the Phillips Dream Station 2. The FDA observed an increase in reports between August 1, 2023 and November 15, 2023 a total of 270 MDRs compared to 30 MDRs in the past 3 years. This matter is not related to the Dream Station 1 Foam recall. Again, do review the entire report and FDA recommendations.
If you after reviewing the websites you have any questions or concerns email us at [email protected]. In subject section type DS2 question. We will make best efforts to get back to your questions. Please do not call the office as we will direct you to submit your questions by email.