FDA recall Z-1322-2023

Product

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.

Distribution

US Nationwide. France, Reunion.

Key facts

Status

Ongoing

Initiation date

2023-02-10

Report date

2023-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2023