Z-1322-2023Class I

Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11...

Name: Z-1322-2023 Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11...
Creator: Philips Respironics, Inc.
Published: 2023-02-10
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2023-02-10 / Open, Classified / root cause: software

FDA source

Philips Respironics, Inc. began a recall of Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive... on 2023-02-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1322-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-02-10
Posted: 2023-04-06
Recalling firm: Respironics, Inc.
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.
Product code: BZD Ventilator, Non-Continuous (Respirator)
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.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: An Important Product Notice was sent to customers on 2/10/23. For DMEs: 1. Should the prescription settings of the device be affected by this issue, the patient may find the device provides different pressure and comfort settings than the patient is accustomed to. 2. The DreamStation is designed to provide CPAP, CPAP-Check, Auto CPAP, Bi-Level and Auto Bi-Level therapy. Affected product can be determined by locating the serial number of the replacement device and verifying it against the serial number noted in this letter below. 3. Affected device serial number(s) are noted in the letter. Enclosed is the letter that should be provided to your affected patients. Replacement product will be provided to you for exchange of affected devices. 4. If you need any further information or support concerning this issue, please contact 1-800-345-6443, prompts 4, 5 or email at [email protected]. For Patients: Affected product can be determined by locating the serial number of the replacement device and verifying it against the serial number noted in this letter below. The device may continue to be used until the replacement device is received. The affected device serial number is noted in the letter. Philips will attempt to contact the patient via phone call to set up replacement and return of the device affected by this issue. No further action is necessary by the patient. Philips will attempt to contact the patient via phone call to set up replacement and return of the device affected by this issue. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-(877)-387-3311 or email at [email protected].
Quantity in commerce: 1233 devices
Distribution: US Nationwide. France, Reunion.
Product codes and lots: 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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1322-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1322-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-06

Product code BZD

K131982Class IIRemstar Auto a-Flex HtRespironics, Inc. / cleared 2013-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)