Philips Respironics Recall of CPAP, BiPAP, Mechanical Ventilator Devices

To Our Sleep Apnea Patients Using Respironics CPAP/BiPAP products:

As you may know, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices on Monday, June 14, 2021. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer caused from toxic gases. Philips Respironics has recommended that you stop using the recalled units and check with your treating sleep specialist to make an informed decision about whether the benefits of continued use outweigh the potential risks. If your sleep specialist is Dr. James Sehloff or Michelle Mortensen, PA, please contact the SSM Health MultiSpecialty Clinic at 608-937-7000 for specific patient guidance, or call your sleep specialist if they are outside of Dodgeville.

At this time, we do not recommend discontinuation of CPAP/BiPAP positive pressure therapy for persons with moderate to severe sleep apnea based solely upon this recall and without consulting your provider. In general, individuals with moderate to severe sleep apnea are at risk of numerous medical problems (including death) from untreated sleep apnea. Even those with mild apnea are at increased risk for daytime sleepiness which adversely affects their safety if left untreated.

Positive pressure therapy, provided by CPAP/BIPAP devices, is the most effective therapy and the current standard of care. Deciding whether to continue your positive pressure therapy should be done in consultation with your treating sleep specialist. The risks associated with your sleep apnea should be weighed against the potential risks identified in the recall notice.

Philips Respironics indicates that it will replace the current insulation foam with new material as quickly as possible and has already begun preparations. We do not yet know the timeframe for device replacement. In addition, the company is recommending that customers and patients halt use of ozone-related cleaning products and adhere to their device instructions for approved cleaning methods.

The company created an online registration process to allow patients to look up their device serial number and start a claim if their unit is affected by the recall. You should register any affected device through the website, Philips.com/src-update, or by phone at 1.877.907.7508.

We will keep you posted as the situation evolves and continue to advocate for your best sleep and health. You also can check on the recall’s latest developments by periodically visiting the recall website. Thank you for your patience and for choosing SSM Health as your medical providers.

Yours,

Upland Hills Health Sleep Disorders Center

Philips Respironics Recall of CPAP, Bilevel Pap and Mechanical Ventilators

Upland Hills Health is monitoring Philips Respironics announcements to understand how Philips Respironics company will correct a recall of its CPAP, BiLevel PAP and mechanical ventilators warning of possible health risks from exposure to degraded sound abatement foam or chemical emissions from the foam. Further information is available in this June 23 Patient Letter.

For patients using BiLevel PAP and CPAP devices, Philips Respironics is advising:

• Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.

The latest information is available on the Philips Respironics website, www.philips.com/src-update or call 1-877-907-7508 for the latest information about the recall.

Philips encourages patients to register affected devices on the recall website.