FDA-Device2023-04-12Class I
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.
Philips Respironics, Inc.
Hazard
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.
Sold states
US Nationwide. France, Reunion.
Affected count
1233 devices
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2023Don't want to check this manually?
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