Medical Device recall notification (U.S. only)
UK HealthCare has recently been made aware that Philips Respironics issued a voluntary recall for several models of its CPAPs, BiLevel PAPs and ventilator devices. The recall is due to two issues related to a type of foam used in these devices.
For more on the recall notice, a complete list of affected products, and potential health risks, please visit philips.com/src-update or call 877-907-7508.
Frequently Asked Questions
How do I determine if my machine was recalled?
The recall only affects devices manufactured by Philips Respironics. Model photos and descriptions of recalled machines, as well as those exempt from the recall, can be found at philips.com/src-update or call 877-907-7508. The durable medical equipment (DME) company that provides your machine and supplies is also a good resource.
What do I need to do if my machine was recalled?
Philips will assist by providing a repair and replacement program if your machine was affected. Begin the registration process here. The website provides information on the status of the recall and how to receive permanent corrective action to address the issue. The site also provides instructions on how to locate an affected device serial number and will guide you through the registration process. You will receive a letter from Philips by mail after you register your device..
If your machine is more than five years old, you may be eligible for a new one based on your insurance company’s current guidelines. Please contact your machine’s ordering provider for a prescription for a new device.
Philips recommends patients stop using ozone-related cleaning products, as they are not FDA-approved for this use. Please follow your device’s “Instructions for Use” manual for approved cleaning methods. Learn more here.
If you are using a home ventilator device, Philips recommends adding an inline bacterial filter. If you do not already have one, please contact the durable medical equipment (DME) company that provides your supplies or the ordering provider.
Are devices still safe or should I stop using my machine immediately?
- For patients using BiLevel PAP and CPAP devices: Philips recommends that you stop using the device and consult with your ordering provider on the benefits of continuing therapy and potential risks. We recommend that you contact your device’s ordering provider as soon as possible to discuss your medical history and symptoms to determine the best course of action for you. Suddenly stopping use of your machine could have significant side effects on your health.
- For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy without consulting the ordering physician to determine appropriate next steps.
What safety issues are related to this recall?
Philips has noted that the foam used in these devices to reduce the sound can start to degrade and produce fumes. The possible health risks associated with the foam identified by Philips include:
- Potential risks from degraded foam exposure, including irritation of the skin, eyes and respiratory tract
- Inflammatory response
- Headache
- Asthma
- Adverse effects to other organs, such as kidneys and liver
- Toxic and carcinogenic effects
The potential risks of exposure due to chemical emissions from the foam include:
- Headache/dizziness
- Irritation of the skin, eyes, nose and respiratory tract
- Hypersensitivity
- Nausea/vomiting
- Toxic and carcinogenic effects
If you feel you have symptoms related to the foam degradation, we s recommend you contact your device’s ordering provider to discuss your symptoms and for further instructions.
How do I contact my machine’s ordering provider to discuss my situation?
Please contact the ordering provider’s clinic by phone or through UK HealthCare MyChart. Let them know that you need an urgent appointment to discuss the status of the recall of your device. UK HealthCare also offers UK TeleCare video visits for your convenience.
When will this issue be fixed?
Philips is notifying affected customers that the company will replace the sound abatement foam with a new material not affected by this issue. At this time, affected devices will either be:
- Replaced with a new or refurbished unit that incorporates the new material, or
- Repaired to replace the sound abatement foam in customer units.
The new material will also replace the current sound abatement foam in future products.
Will I receive a loaner device until Philips repairs or replaces my current one?
At this time, it is unlikely that you will receive a loaner device while awaiting repairs/replacement because of limited supplies. You are welcome to ask your durable medical equipment (DME) company in case they have a device available
Will I receive a defective device for use?
At this time, affected devices are on manufacturing and ship hold. The company plans to install new sound abatement foam material not affected by the reported issues in these devices.
My device is on the recall list but looks fine. Should I still try to get a replacement/repairs?
Philips has stated that even if no obvious debris is noted in the tubing, foam degradation may already be occurring as well as producing fumes. We recommend that you register your device with Philips and contact your ordering provider.
Is it possible other devices are affected?
Philips states it has completed an analysis in accordance with its Quality Management System. All affected products identified in the analysis are included on the recall list.