Philips Recall Information
Philips Respironics Product Recall: Information for all Peak 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 Alternatively, contact the manufacturer at 1-877-907-7508
to assist with device registration.
- For further questions or inquiries, please complete the Philips Recall Form and a Peak Sleep Therapist will return your call.
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
Quick tips about the recall
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.
On February 10, 2023, Philips sent affected customers and patients an Important Product Notice to notify affected patients.
What to Do:
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
September 26, 2022
- Health Canada has issued a public advisory in response to the Philips Respironics mask regarding the magnets of the following masks:
- Amara View FFM – has been discontinued
- DreamWisp Nasal Mask
- DreamWear FFM
- Wisp and Wisp Youth Nasal Mask
- There is a safety concern that the magnets can interfere with certain implanted metallic medical devices and metallic objects int he body. It is also noted the risks are both the user of the mask (if they have a metallic medically implanted device) AND for people near the person using the mask.
Recommendations for Patients:
- Stop use of the recalled mask and switch to a non-magnetic mask if available, if you or someone near you when using the recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.
- You may continue using the mask, if you or someone near you when using the recalled mask, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.
Recommendations for Health Care Providers:
- Tell patients to stop use of the recalled mask and switch to a non-magnetic mask if available, if they or someone near them when using a recalled mask have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.
- Do not prescribe use of the recalled masks on patients who have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks. Prescribers should also ask about any other people who may be at risk for injury or death if they are near a recalled mask while it is being used.
Please view the recall list on the Government of Canada website here.
July 27, 2022
Health Canada issued a statement on July 27, 2022 with updates on the progress of remediation plan set out by Philips Respironics.
The notice states that Philips has confirmed that they will be repairing ALL devices affected by the recall regardless of the age of the device. It also states that Philips may replace devices with the same model, or a different Philips device that meets the needs of the patient and has advised Health Canada that they expect to complete the repair and replacement program by end of 2023.
For further information on this update by Health Canada visit https://recalls-rappels.canada.ca/en/alert-recall/philips-respironics-recalls-several-models-cpap-and-bilevel-pap-machines-and
Health Canada has also requested that Philips update its Canadian website to provide more information to Canadians affected by the recall. Philips Respironics’ Canadian website https://www.philips.ca/healthcare/e/sleep/communications/src-update
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, 2021Philips 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.”