May 16, 2023
Amsterdam, the Netherlands - Philips.*
The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices under the recall notification/field safety notice* i.e., the first-generation DreamStation, System One and DreamStation Go devices, representing approximately 95% of the registered devices globally. The assessments build on the previous updates in December 2021, June 2022, and December 2022. Additionally, tests and analyses have been completed for first-generation DreamStation devices that have been exposed to ozone cleaning.
The test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel.
Philips Respironics has provided the summary of the completed set of test results and analyses for the CPAP/BiPAP sleep therapy devices to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach a different conclusion.
The full press release is available here.
* Voluntary recall notification in the US/field safety notice for the rest of the world.
For media questions, please contact:
Steve Klink
Philips Global Press Office
Tel.: +31 6 10888824
E-mail: steve.klink@philips.com
Elco van Groningen
Philips Global Press Office
Tel.: +31 6 81039584
E-mail: elco.van.groningen@philips.com
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Forward-looking statements
This statement contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips' organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.
Attachment
- Philips provides update on completed set of test results for cpap bipap sleep therapy devices (https://ml-eu.globenewswire.com/Resource/Download/9df4022a-7884-4b37-9bc9-5d8c8cdc7aa5)
