CLASS I ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

Philips DreamStation Auto BiPAP and CPAP recalled by Philips Respironics

Philips Respironics is recalling Philips DreamStation Auto BiPAP and CPAP, distributed nationwide in the US. The recall was initiated on 10 Feb 2023 and the FDA has classified it as Class I.

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Quantity recalled1233 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1322-2023
FDA event ID: 91837
Recalling firm: Philips Respironics, Murrysville, PA
Classification: Class I
Status: Ongoing
Recall initiated: 10 Feb 2023
FDA classified: 6 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

10 Feb 2023	Recall initiated by company
6 Apr 2023	Classified by FDA	+55 days
12 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide. France, Reunion.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN/HIBC: HIBCUCDSX500S11, GTINUDSX500S11F, HIBCUDSX700S11, GTINUDSX700S11F, GTINUFRX500S14; Serial Numbers: J24421197E010, J201506009824, J20558590552C, J21032984C317, J21209966AF9A, J217958772FC0, J232909614499, J232986192AC6, J239466352C09, J26991149FC9E, J285824687E46, J169457430155, J18040704DF8F, J181773679463, J18342322DF63, J185233902700, J18531602D885, J185960074278, J186478392B1E, J186751020701, J187324621476, J188283663434, J18833555314F, J188893710940, J188945627411, J18897822C9C3, J1891938599E3, J18951421667A, J189800136CAE, J19017668F54F, J190409177B02, J1906385333DF, J190720281139, J19096115A93C, J19100094327C, J19295259C6CF, J193008337527, J19336718E4D5, J193380465154, J1934276067A5, J19397348A91F, J193977064460, J194128342F7B, J19434423BAAD, J19438211F23A, J194617995638, J19560765070C, J19572114BF66, J19599936C8AB, J196015973930, J196616324711, J196622212AFE, J19663444E3E1, J19681407EED4, J196887815325, J19693965545B, J197027417820, J19740100CC76, J197462035A13, 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Where was it sold?

US Nationwide. France, Reunion.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Respironics

All 76

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy EV300 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo Universal recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo O2 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide

Other CPAP & Ventilators recalls

All 554

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide