Recall Notification

August 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. 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.

We have, as requested by Philips, submitted a list of all affected devices, including contact information for all affected patients. They have indicated that they will be reaching out to all affected patients and will be handling the replacement or repair of patients equipment directly, and that there will be no involvement from the HME company like us in this process. Philips recently updated their advice and indicated that the FDA is requiring all affected patients to personally register their devices on the Philips designated site, in addition to our sending in patient information. 

Per written correspondence from Philips to a patient of ours that was shared with us, Philips states they are "working diligently to replace or repair devices as soon as possible. Based on current estimates of impacted devices worldwide, we are working towards completing this effort within approximately 12 months." All updates related to the recall can be found on their site: philips.com/SRC-update.

We will continue to keep you updated with any new information or instruction that we receive regarding this recall. We appreciate your patience. 

Sincerely,

Sea Breeze Sleep and Medical Services LLC