Philips Respironics Product Recall

PHILLIPS RECALL: Information for all Peak Sleep Clients

Peak Sleep Clinic remains in close contact with Philips Respironics with regards to the product recall. We are currently in the process of replacing affected CPAP devices and will continue to assist all patients who have purchased a recalled device from Peak Sleep Clinic. We will be contacting patients in priority sequence to ensure that the most vulnerable patients are seen first.

No action is required on your part – Peak Sleep Clinic will call you to replace your machine. Peak Sleep understands how important your therapy is to your health and well-being. We appreciate your patience as we navigate through this challenge.

Next Steps:

Check to see if your device serial number is affected by the recall.
Register your recalled device or contact the manufacturer at 1-877-907-7508 to assist with device registration.
For further questions or inquiries, please complete the following form and a Peak Sleep Therapist will return your call.
- The link to the form can be reached here: Phillips Recall Information

Peak Sleep understands how important your therapy is to your health and well-being. We appreciate your patience as we navigate through this challenge.

Sincerely,
Sleep and Respiratory Team – Peak Sleep Clinics

Updates from PHILLIPS:

April 7, 2023

Philips Respironics has issued a new recall for some specific Dreamstation machines as part of their current Replacement program. The list of affected serial numbers can be found here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=198972

Peak Sleep Clinic has received no notification from Philips and we have confirmed that we did not receive any of the affected serial numbers on their list. All Replaced Dreamstation machines are functioning as they should and the issue is the SERIAL NUMBER.

Reason for Recall:
Certain reworked Philips Dreamstations were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to e delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the Dreamstation is not working the way the doctor intended or prescribed.

What to Do:
On February 10, 2023, Philips sent affected customers and patients an Important Product Notice to notify affected patients.

More information can be found here: https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-dreamstation-cpap-bipap-machines-risk-they-may-deliver

June 28, 2022

Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

December 23, 2021

Philips provides update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification

September 3, 2021

Cleaning and inspection instructions for existing accessories Before resuming therapy on your new or replacement machine, you or your equipment provider must visually inspect the following accessories for evidence of particulate contamination:

Tubing
Mask components (mask, cushions and integrated tubing)
Humidifier tank and seals (if applicable)

If visible particles are evident on any of these components:

Discard components and contact your Homecare provider / Durable
Medical Equipment provider (DME) for replacement

If there is no evidence of particles on any of these components:

Clean each component per their respective instructions for use
Re-assemble and resume therapy on your new device

August 30, 2021

A message from David Ferguson, Executive Vice President, Philips Business Leader Sleep and Respiratory Care

To the community of patients, providers and practitioners

As part of our commitment for ongoing communication regarding the recent recall notification (U.S. only) / field safety notice (outside of U.S.) of certain products in our Sleep and Respiratory Care portfolio, I wanted to take this opportunity to share some important updates with you.

In recent weeks, we have been actively working with global competent authorities and regulatory bodies to align on the remediation process. This process will enable the repair or replacement of the impacted devices while putting patient safety and speed of resolution as the top priorities

June 16, 2021

Philips Respironics is voluntarily recalling a number of medical devices including Dreamstation and System One CPAPs. For your immediate
reference Philips Respironics makes the following statement regarding foam degradation exposure:

Potential Hazard: Philips has determined from user reports and lab testing that under certain circumstances the foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user of its Continuous Positive Airway Pressure (CPAP),
BiLevel Positive Airway Pressure (BiLevel PAP) and Mechanical Ventilator devices. The foam degradation may be exacerbated by environmental
conditions of higher temperatures and humidity in certain regions. Unauthorized cleaning methods such as ozone may accelerate potential
degradation.