Sleep and Respiratory Care Bulletin #5
We know how important it is for you and your patients to be informed on all aspects of their sleep
therapy and treatment. This bulletin was created to help address common questions and concerns
as well as provide a status update on remediation efforts as they become available. Please find below
some recent information that we wanted to bring to your attention. We invite you to consult our
website regularly to keep informed of updates and for additional information on this field safety
notice: Visit our Clinicians information page.
1. Trilogy 100/200 News
We are pleased to confirm we are beginning the rework of affected Trilogy 100/200 devices at Philips
Service Centers and designated remanufacturing site. The full remediation process for Trilogy 100/200
repair kits will take approximately 12-14 months to complete.
Customers with registered devices will be contacted in the following weeks with further details of
the process, including signing a Recalled Device Services Agreement for Trilogy to authorize customer
payment for return and set up as well as the opportunity to clarify where your remediated devices
should be shipped, required packaging, serial numbers prepared for return, etc.
2. Useful information for your patients
We continue to work to ensure that your patients are provided with information needed to feel
confident in using their replacement device, including:
• While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam
component, the sound abatement foam in all new and recertified devices is a silicone foam which
has been allowed for use by the FDA in DreamStation 2 devices.
• All recertified devices include a new blower and air pathway and are cleaned and disinfected.
• The recertified device may show some external cosmetic blemishes and a different manufacturing
date than your original device, it has undergone rigorous verification and validation procedures to
ensure that standards of safety, performance and quality are met.
• The replacement device’s manufacturing warranty has been adjusted accordingly. This warranty
covers all labor and materials to repair the replacement device free of charge.
3. Independent analysis of health risks
In May 2022, an analysis was published online in the European Respiratory Journal1 that concluded
that sustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with
other manufacturers’ devices, was not associated with an increased risk of cancer after a median
follow-up time of 7.2 years. The analysis and conclusion were based on data from a large multicenter
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cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648
Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.