Medical Device Recall Notification – Philips Respironics Sleep and Respiratory Care devices

by | Jan 6, 2022 | FDA | 0 comments

Device registration and recall contact information

Recall notification (225.0KB) 

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877-907-7508

In November 2021, Philips updated the guidance in its June 14, 2021 U.S. recall notifications for certain CPAP, BiPAP and Mechanical Ventilator devices to align them with FDA’s recommendations in connection with these recalls. 

​​This updated guidance is based on the same test results up to June 2021 and is intended to provide broader options for physicians advising patients of affected devices, to better account for a wide variety of clinical use cases for patient medical conditions.

The updated recall notification advises patients and customers to take the following actions:

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.

View affected BiLevel PAP and CPAP sleep apnea devices 

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.

View affected ventilators 

There is nothing we take more seriously than providing patients with high quality products that are safe and reliable. Finding out that your device has been recalled can be distressing and we truly appreciate your patience during this time.
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