NOTE: The following notice does not apply to patients who own ResMed or Fisher & Paykel brand CPAP or BIPAP devices. Please disregard this notice if you do. We apologize for any inconvenience as we work to inform our community of an industry-wide recall situation.
To All Our Patients,
We want to share with you some positive news regarding the Philips Respironics Recall of PAP therapy devices.
At this time, we can report that patients have begun to receive replacement machines from Philips Respironics. So far, all reported replacements are in the form of the new Dreamstation 2 model. However, Philips Respironics has told us that some patients will receive the original Dreamstation with a new motor and foam filter once the FDA clears the new parts. We understand that the FDA approved a motor and foam kit for repairs to current devices, but it is unclear how or when those repair kits will be utilized. The FDA approval on the motor and foam to be manufactured into new devices is still pending. Once approved, this will drastically increase the timeliness of replacement devices being shipped.
As far as we know, Bi-Level (BIPAP) devices will not begin shipping until the new motor/foam is approved for manufacturing; there currently is no Dreamstation 2 BIPAP. Meanwhile, BIPAP ST and BIPAP ASV devices will not be shipped to patients directly from Philips Respironics. Instead, either replacement devices or repair kits will be sent to Quality DME, and we will arrange with you to repair or replace your device. There is not yet a timeline of when this will happen.
Important information regarding your replacement device:
- If you have not registered, you will not receive a replacement device. Be sure to register here.
2. Philips Respironics will ship your replacement along with a return label for your recalled device. Be sure to return the old device as instructed by Philips Respironics.
3. When you receive your replacement device, please notify us at [email protected] along with the new serial number so we can be sure your new device is updated in our system.
4. If you receive a Dreamstation 2, there will be several included resources on how to use it. You can also view our training video here.
We are hopeful that more of you will begin to receive replacements shortly. Reportedly, the volume of machines being sent out is growing rapidly, but the number of patients needing them is massive. While Philips Respironics has reported it will take close to a year to complete the entirety of the recall, it is our understanding that those who have already registered will receive a replacement significantly sooner.
As the recall process continues, we will do our best to communicate with you any significant updates. We understand it has been longer than some had wished since our last outreach, but we want to ensure that the information we share is accurate and substantial. The information we receive from Philips Respironics may often create more questions than answers. It would be unfair to our customers to provide inaccurate information that does not bring you closer to effective therapy. We want everyone to have access to the therapy they need to maintain a healthy life, so our focus will continue to be on resolving this recall process.
As always, please direct any questions to [email protected].
President, Quality DME, Inc.
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