Philips PAP Device Recall Update - January 2022
Philips provided the following update on January 25, 2022. To view the original notice click here.
Dear Valued Customer,
As we enter 2022, we at Philips Respironics wish to provide you with an update on the status of the ongoing field safety notice announced in June 2021 for certain products in our CPAP, BiLevel PAP and mechanical ventilator portfolio.
As always, patient safety remains our top priority, and our intention is to ensure that as many patients as possible can continue safely with therapy. We are steadfast in our commitment to transparent communication, and we appreciate your cooperation and help in this continued partnership to address this issue with our patients across the globe.
We continue to engage with our patients, customers, competent authorities and clinicians, working together to accelerate the actions needed to complete this remediation in all affected markets.
Continued Commitment to Health and Safety Assessment
We are encouraged by the VOC test results to date for the first-generation DreamStation devices, which we published in December 2021.
The results indicate that VOCs do not exceed safe exposure thresholds specified in the applicable safety standards (e.g. ISO 18562). Using conservative health-protective exposure thresholds, the additional testing suggests no increased risk for adverse health effects in the general patient population nor the higher risk patient population as a result of VOC exposure. As we announced in December, it is important to note that the tested DreamStation devices were not exposed to ozone cleaning, as per the device instructions for use.
In accordance with the Philips Quality Management System, further health risk assessments are ongoing. Comprehensive particulate testing and analyses are expected to be completed in the second quarter of 2022, as testing protocols in compliance with the full extent of the relevant ISO standards (ISO 18562 and ISO 10993) for all affected product platforms require long lead times. We will continue to provide timely updates on findings from these assessments.
A summary of the test findings is available within the Philips Field Action Notification website.
In order to ensure maximum awareness and transparency to patients, we would kindly ask you to reinforce this finding as part of your regular interactions with patients.
We will continue to share details such as VOC analysis from the voluntary field action test and research program. Philips Respironics remains fully committed to this remediation and will continue to dedicate significant time and resources throughout 2022.
We would like to thank you for your support and patience in this very challenging time. Together we are making progress with our remediation program and continued testing. We sincerely appreciate your partnership and continued care.
Eline de Graaf
SRC Business Market Leader