RESPIRONICS RECALL INFORMATION
November 28, 2022 - Update
If you have not received your recall replacement PAP machine please know you are not alone! We have many patients who registered their devices as early as June of 2021 and are still waiting for their new machine to arrive.
Patients with older models, such as the System One device, are now being offered $50.00 for their machine or require ACTION from their DME provider prior to replacement. Please check your email to make sure you have not missed any important messages from Philips Respironics regarding the mandatory steps.
As a reminder, Philips will mail replacement devices directly to your home address. These machines should be pre-programmed with your current settings and are ready to use out of the box.
***IMPORTANT*** - If you receive a replacement DreamStation one device (white unit), you will need to remove the modem cartridge from your old device and put it in the new one.
December 29, 2021 - Update
If you have questions regarding your recall replacement PAP machine Philips has provided the following phone numbers for more information:
Recall Registration Line: 877-907-7508
Use for:
Registration assistance
Post registration and general recall questions
Pre-shipment phone support line
Post delivery patient support line: 833-262-1871
Use for:
Patient PAP device setup and question support
Post-shipment phone support line
November 18, 2021 - Replacement Machine
If you have received your replacement Dreamstation 2 device please note the following:
Your machine comes pre-programmed with all of your current pressure and comfort settings.
Your machine also comes fully connected to our online database and will be transmitting your data after use.
You do not need to notify our office about your replacement machine arrival. Simply unbox it and use it immediately.
If you have questions about the set up of your Dreamstation 2 please refer to the following videos:
Novermber 16, 2021 - Update
The FDA released their first update on the Philips recall this week. Click here to read the report.
The main point of the update was to inform the public about further testing that will take place on the new silicone-based sound abatement foam which was previously approved by the FDA. Those who have received replacement machines are recommended to use them until further notice, as the risk-benefit analysis determined OSA treatment to be the highest priority.
October 20, 2021 - Update
We know everyone is patiently waiting for more information regarding the replacement of all recalled Philips PAP machines. At this time the only update we have is that some of our patients have begun to receive their new machines via mail from Philips. We do not have access to any queue of patients to determine when someone should expect their device. As far as we know the process is completely at random.
Only patients who have registered their device with Philips will receive a replacement machine. Please use the button in the banner image above to register if you have not done so already.
June 23, 2021 - Detailed Statement
We are notifying all our patients about an important announcement first posted on our website on June 14, 2021. Philips Respironics announced it was voluntarily recalling all Dreamstation 1 and System One model CPAP/Bilevel machines. If you are not currently using a Philips CPAP machine, you can ignore this notification as it does not apply to other CPAP brands which you may use.
If you use a Philips Dreamstation 2, which came out in April 2021, the recall does not apply to your machine, therefore you need not be concerned about either the cause or effect of the recall. Continue to use your product as you have been directed.
RECALL DETAILS
Philips chose to voluntarily recall its PAP machines out of concern over rare (0.03% of users) and relatively mild symptoms that have been reported by some who use the machines. Those symptoms include:
-Headache
-Airway irritation
-Airway inflammation
-Respiratory symptoms
If you have any of these symptoms, and if you have been using one of the affected Philips PAP machines, you should contact our office and speak with one of our professionals who can help determine if your symptoms are related to the recall concern.
Philips’ data, which is limited, suggests the polyurethane foam used within their PAP machines may, in some circumstances, break down into small particles that can be ingested or inhaled and cause symptoms. There is also a concern the polyurethane may have toxic or carcinogenic features. There is no proof this is true; however, Philips was sufficiently concerned to voluntarily recall the product.
Philips has also advised that patients who have reported these rare symptoms may be users of the ozone cleaning systems, such as SoClean. If you are currently using such a system to clean your PAP machine, we suggest you stop doing so and use a benign solution, such as a water/vinegar mixture (3 parts water, 1 part vinegar) to clean your equipment.
OUR RECOMMENDATION
We want to emphasize that this recall is limited to only Philips brand PAP units and no others. Some patients have questioned their continued use of their PAP equipment because of this recall. We are of the opinion that the risks which prompted the recall are quite small and, compared with the well-proven, serious risks of not using CPAP/Bilevel during sleep, and having periods of sleep apnea, the best choice is to continue to use your machine if you are not having one or more of the symptoms listed above. Again, if you are having any of these symptoms, please contact our office to discuss your treatment options going forward.
MOVING FORWARD
Data is continuing to be accumulated on the safety of the Philips PAP equipment. We are following this data very carefully and will update you when more information is available. In the meantime, please know that your health and safety is our paramount concern, and we are here to answer any questions you may have. We know that dramatic news, such as a recall of a product you are using, can cause anxious feelings. We hope this letter lessens any anxiety you may have and provides you the assurance that we are here to help you through this uncertain time.
June 18, 2021 - Update
Please use the following link to check if your PAP device is eligible for replacement and/or register your device:
https://www.philipssrcupdate.expertinquiry.com/
June 15, 2021 - Update
Philips Respironics has informed us that they are implementing a repair and replacement program for all affected PAP devices, however, the details of this program are not finalized. We will provide further information as it becomes available.
The list of affected devices has also been updated to include Philips Respironics System One PAP devices, as well as ASV machines on both Dreamstation and System one platforms (see below for a complete list). Please use the same recommendation listed below if you use one of these devices.
June 14, 2021
Today Philips Respironics issued a statement outlining a voluntary recall of all original Dreamstation* and older model CPAP and Bilevel positive airway pressure devices due to potential health risks related to an internal foam component using polyester-based polyurethane (PE-PUR).
Philips reports there is a slight risk of this foam degrading into particles which may be inhaled or ingested during use. The consumer complaint rate was very low at 0.03% (3 in 10,000) in 2020. The highest risk of exposure appears to be in conjunction with ozone cleaning machines such as SoClean devices.
We strongly recommend stopping use of ozone CPAP cleaning machines, effective immediately.
Upon initial assessment of the data provided we believe that, in nearly all patients, the benefits of treating sleep apnea using PAP therapy far outweigh the non-lethal health risks reported in the recall.
For most patients, We recommend continuing use of CPAP or Bi-level devices until further data is disclosed.
The reported symptoms of those affected included:
Headache
Irritation
Inflammation
Respiratory issues
Possible toxic and carcinogenic effects
If you exhibit any of the above symptoms, please contact our office or your designated sleep specialist immediately.
For additional support on this recall please call Philips at 877-907-7508.
* At this time the recall does NOT affect Dreamstation 2 devices released in 2021.
Click HERE to review the Philips recall notification.
Click HERE for a complete list of affected devices.