A medical device recall was announced by Philips for three sleep and respiratory care devices. A medical device recall occurs when the device manufacturer or the Food and Drug Administration (FDA) has found a possible problem that could affect patient safety and health.
What devices are being recalled?
The recall is for the following Phillips devices:
- Bi-Level Positive Airway Pressure (Bi-Level PAP).
- Continuous Positive Airway Pressure (CPAP).
- Mechanical ventilator devices.
The majority of the devices are in the first-generation DreamStation product family.
To see the recall notice, please visit the Philips website. (Note: This website is only available in English.)
What do you need to do?
- If you are using a Bi-Level PAP or a CPAP device:
Call your primary care provider (PCP). Ask your doctor if your device was recalled and decide together what the best options are for continued treatment.
- If you are using a life-sustaining mechanical ventilator device:
Call your PCP. Do not stop or change your prescribed therapy until you have talked to your PCP.
If you need further assistance, please call the Alliance’s Member Services Department at 800-700-3874 (TTY: 711).
Language assistance is available to you at no cost.