Important information regarding the recall of certain Philips Respironics patient interface devices (face and nasal masks).

On September 15th, 2022 Philips Respironics announced that it is updating the existing contraindications and warnings of certain patient interface devices (face and nasal masks). The affected masks contain magnets which can potentially affect the functioning and/or induce the movement/dislocation of medical implants or medical devices that can be impacted by the magnetic fields.

For more information about the recall, click here.

Patient safety is always our concern. We are working with Philips Respironics daily to ensure adherence to and facilitation with the recall process. We are waiting to receive specific instructions from Philips on the replacement program.

For frequently asked questions, click here.

For the latest updates, click here.

If you have additional questions or concerns, please contact the dedicated Philips Patient Help Line at 1-877-387-3311.

Dear client,

Philips provided the following update on June 28, 2022. To view the original notice click here.

Dear client,

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.

Sincerely,
Eline de Graaf
SRC Business Market Leader

Latest Update on Philips Recall and PAP Device Replacement/Repair

Dear client,

We continue to keep you informed regarding the Philips Recall.  Philips advised that affected devices may take up to twelve months to replace or repair.

The following is an excerpt taken from the Philips Registration team:

“What to expect next:

We regret that it may take some time to replace affected devices. The planned repair for the affected devices involves certain design changes, which in some markets may include review and/or authorization by the relevant regulatory agencies. We understand the impact of this issue and we sincerely regret this disruption.

For additional questions:

For more information and updates, please visit Philips.com/src-update where we will be updating answers to frequently asked questions (FAQ) as more information becomes available or call 1-877-907-7508 in the US and US territories or (0044) 20 8089 3822 outside the US.”

What we are doing at Canadian Home Healthcare to prevent the spread of COVID-19 and continue to safely serve you.