Tower Health and its affiliated healthcare providers would like to make you aware of a voluntary recall issued by Philips Respironics for several of its ventilator products. The recalled products include Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices.
The recall is associated with foam that is used to make the devices quieter. Philips has learned that this foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user.
Phillips is working on a solution for this problem, and has asked each user to register their device online or by phone (877-907-7508). Patients can also contact their durable medical equipment (DME) company to identify the make and model of their device. You can also contact your health insurance provider for additional guidance. More information from Philips about this matter may be found here.
If your device is on the list of affected devices
For patients on life-sustaining therapy (Trilogy 100 and 200), DO NOT STOP using this ventilator. Please call your healthcare provider to discuss alternative options.
For patients using the Bi-Level PAP or CPAP, we encourage you to speak to your healthcare provider about whether to continue using your device. We know that there are varying levels of need for these machines, and want to ensure that your provider can help make a decision that is right for your care.
If your device is not on the list of affected devices
Continue your therapy as prescribed. The recall does not apply to you.
If you are unable to determine the make and model of your CPAP machine
Contact your durable medical equipment (DME) company that will have this information on file.
Potential safety hazards Philips has reported
- The potential risks of exposure to degraded foam include irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g., kidneys and liver), and cancer-causing effects.
- The potential risks of exposure to chemical emissions include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and cancer-causing effects.