Philips Respironics Recall
Philips Respironics Recall Information
On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall.
If you received your device prior to April 21, 2021, then your device is included in the recall. Philips Respironics reported that 3 out of 10,000 patients reported issues and there have been no deaths.
If you have a CPAP or BiPAP device subject to the voluntary recall, Philips Respironics recommends you stop using the device and contact your physician to discuss treatment alternatives, or whether the risks of untreated obstructive sleep apnea outweigh the risks of continued use. This is a personal decision between you and your physician.
Recall and Replacement Process
Philips Respironics is managing the recall and replacement process, handling all recall notices and CPAP/BiPAP replacements directly. All devices will be replaced through the Philips Respironics Recall process.
Philips Respironics has received FDA approval for replacement of the sound abatement foam to “rework” or repair on DreamStation 1 devices and has started sending out replacements to patients. The repair must be performed by a licensed re-manufacturer, therefore suppliers such as Rotech will not be able to perform the repair.
As they become available, Philips Respironics will ship you a reworked/repaired DreamStation 1 device to your home as a replacement. When the replacement is received, you will pack up the recalled device and Philips will pay for it to be shipped back to their warehouse.
Please note: when you receive your replacement device from Philips Respironics, you will need to plug it in, turn it on, and let it sit for at least 5 minutes to allow for an auto-update of the prescribed settings. You may also visit our Sleep Apnea Resources page for links to instructional videos.
The FDA approval for sound abatement foam does not apply to any other devices affected by the recall, such as Trilogy ventilators. Philips Respironics continues to work with the FDA regarding repair and replacement of the other recalled devices.
Philips Respironics is not sending any DME companies, including Rotech Healthcare, new or replacement CPAP/BiPAP devices. One hundred percent (100%) of Philips’ current CPAP manufacturing capacity is dedicated to replacing registered recalled devices. This recall affects approximately 4 million devices; as a result there is a worldwide shortage of CPAP/BiPAP devices.
Rotech Healthcare does not have devices in stock at our locations to replace your machine. Please note, both the FDA and Medicare are aware of this.
Recalled CPAP/BiPAP Devices:
If you are currently renting your CPAP/BiPAP device; more specifically if:
- you have been set up within the last 13 months,
- have been advised by your doctor to stop using it,
- or if you choose to stop using it,
please return the CPAP/BiPAP device to your servicing location and we will discontinue billing for the device.
Once a non-recalled device becomes available, we will contact you to provide a replacement and resume billing.
If you choose to keep the recalled device, as this is a voluntary recall; billing will continue until the CPAP/BiPAP device becomes purchased, based on your insurance guidelines.
Recalled Ventilator Devices
If you have a Ventilator device subject to the recall, Philips Respironics recommends that you continue to use the device and not alter your prescription, but speak with your physician about the risks.
From setup, Rotech Healthcare supplies all ventilators with inline bacterial filters so you should already have this with your device. Philips Respironics has submitted a Repair Kit for the replacement of the ventilator sound abatement foam to the FDA and is awaiting approval. Once the kit receives FDA approval, they will be distributed to all DME companies and an in-home visit to repair the ventilator will be scheduled with your servicing Rotech location.
Unfortunately, due to this recall there is a worldwide shortage of ventilators and Philips Respironics is not providing DME companies any ventilators to replace our existing ventilator in your home. Rotech Healthcare will be in contact with you as soon as the repair kits are disbursed.
For clinical information on inline bacterial filters, visit the Philips Respironics website.
registration and more information
If you have not yet done so, please register your PAP or ventilator device with Philips.
You may also visit the Philips Respironics Recall website for more information, including a comprehensive list of affected devices and a questions and answers section.
Additional Resources from Philips Respironics
We thank you for your patience in regards to this recall.
Rotech is in communication with Philips Respironics and will continue to post updates to this page as we receive more information.