Medical Device recall notification (U.S. only) /
field safety notice (Outside of U.S.)
field safety notice (Outside of U.S.)
Philips Respironics
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News and Updates > Important update to Philips US recall notification
Important update to Philips US recall notification
November 16, 2021
Philips has updated the US recall notification to align with the FDA’s recommendation in connection with these recalls and provide broader guidance on use.
For patients using BiLevel PAP and CPAP devices, consult with your physician on a suitable treatment plan.
This guidance has been updated from our previous recommendation to stop therapy before consulting with your physician. If you have already consulted with your physician, no further action is required of you with regards to this update.
For patients using life-sustaining ventilation, continue prescribed therapy.
There are no updates to this guidance. Consult with your physician as soon as possible to determine appropriate next steps.
What to expect next
Clinical information has been made available to your care teams to help them make the best decision about your treatment plan. Since your physician knows your medical history, they are the most qualified person to determine the benefit or risk of staying on your therapy until you receive your replacement device.
We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating and that timing is critical. We are working hard to complete this recall and will stay in communication with both you and your care team share the most up-to-date information. While we have already made progress in shipping replacement devices, and have increased our production capacity, we anticipate the repair and replacement program in the US will take through approximately September 2022 to complete.
You can also visit philips.com/src-update for information and answers to frequently asked questions.
If you haven't yet registered your device
* This is a recall notification for the US only, and a field safety notice for the rest of the world. In the US, the recall notification has been classified by the FDA as a Class I recall. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices.
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