Recall Notification

June 23, 2021

 

Dear Patients:

We have been notified by Philips that they have issued a recall on System One and DreamStation One CPAP and BiPAP devices, to include all serial numbers and all dates of manufacture.

At this time, Philips has stated that there are possible health risks including exposure to degraded sound abatement foam. Because of this, they have put shipment holds on all affected products.

We are in constant communication with Philips at this time. They state that they have a comprehensive correction plan and that they will be working to address all affected devices as expeditiously as possible. They are posting all updates to the designated site for this recall: philips.com/SRC-update.

Philips is currently advising that all patients using one of their CPAP or Bi-level devices discontinue use and consult with physicians to determine the benefits of continuing therapy and potential risks.


At this time, Philips has not informed us if devices will be repaired or replaced. They have stated that they will be reaching out to all affected patients and facilitating the resolution of the issue. A timeline has not been provided at this time, however they state that they have ramped up production and are working aggresively to resolve the problem.

At this time, they are not shipping replacement devices or allowing us to submit requests for replacements or service related to this warranty. They have, however, created a patient registration link on the above listed website where patients can initiate a request.


We will continue to keep you updated with any new information or instruction that we receive regarding this recall. We appreciate your patience and do encourage you to consult with your physician for advice regarding if you should continue using an affected device or not.

Sincerely,

Sea Breeze Sleep and Medical Services LLC