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.
- 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.
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:
- 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
1. https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220628-philips-provides-update-on-philips-respironics-pe-pur-sound-abatement-foam-test-and-research-program.html – released June 28, 2022
2. Philips Recall Update – (attached PDF) – released January 25, 2022
3. Health Canada Philips Recall Alert (https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76137a-eng.php?bcgovtm=20200506_GCPE_AM_COVID_9_NOTIFICATION_BCGOV_BCGOV_EN_BC__NOTIFICATION) – released July 30, 2021
4. CTS Position statement (https://cts-sct.ca/wp-content/uploads/2021/08/CTS_CSS_CSRT-Phillips-Recall-Statement_final-July-9_2021.pdf) – released July 9, 2021
5. Philips recall Original notice (https://www.philips.ca/healthcare/e/sleep/communications/src-update) – released June 14, 2021