PlainRecalls
FDA Devices Critical Class I Ongoing

Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.

Reported: April 12, 2023 Initiated: February 10, 2023 #Z-1322-2023

Product Description

Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.

Reason for Recall

A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.

Details

Recalling Firm
Philips Respironics, Inc.
Units Affected
1233 devices
Distribution
US Nationwide. France, Reunion.
Location
Murrysville, PA

Frequently Asked Questions

What product was recalled?
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.. Recalled by Philips Respironics, Inc.. Units affected: 1233 devices.
Why was this product recalled?
A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 12, 2023. Severity: Critical. Recall number: Z-1322-2023.