Lehigh Valley Health Network : Recall on Philips CPAP Devices

As your health partner, LVHN would like to make you aware of a voluntary recall issued by Phillips for several of its ventilator products. Our goal is to keep you informed and ensure patients using these products receive the treatment they need.

Recalled Phillips products

The recalled Phillips 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. The foam may degrade into particles that can be inhaled by the user or produce certain chemical emissions. The recalls apply to specific, but not all models of CPAP devices. The recall does not apply to CPAP machines made by ResMed or other manufacturers.

How to determine if your device is recalled

If your device is on the list of affected devices

LVHN recommends continuing CPAP therapy, pending further information, if you have any of these conditions:

• Symptomatic obstructive sleep apnea
• Obstructive sleep apnea and cardiopulmonary disease
• The need for treatment to maintain a commercial driver's license

The health risks associated with discontinuing CPAP therapy for patients with these conditions outweigh the potential safety hazards currently reported by Philips associated with the recalled products.

If your device is not on the list of affected devices

Continue CPAP as prescribed. The recall does not apply to you.

If you are unable to determine the make and model of your CPAP machine

Contact the 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 affects.
• The potential risks of exposure to chemical emissions include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and cancer-causing affects.