Recall Z-1322-2023— Philips Respironics, Inc.

Name: FDA recall Z-1322-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-10

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2023-02-10. It names one FDA 510(k) clearance: K131982. 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: 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..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-02-10
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K131982 — REMSTAR AUTO A-FLEX HTRespironics, Inc.·cleared 2013-10-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.