Philips DreamStation Auto BiPAP and CPAP — Class I medical device recall Z-1322-2023
Ongoing recall by Philips Respironics, Inc., reported 2023-04-12, distributed nationwide. A limited number of remediated Philips DreamStation units may experience communication issues when connecting
| Recall number | Z-1322-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2023-02-10 |
| Classified | 2023-04-06 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 1,233 devices |
| UPC / GTIN / UDI-DI | 00185233902700, 00188945627411, 00193008337527, 00199812928531, 00206521624644, 00207334130070, 00213072535190, 00214147517967, 00225926847991, 00226477679598, 00232885990026, 00237558050151, 00238902417781, 00239331008342, 00241049875352, 00241312139853, 00245713049254, 00254303401945, 00254513137245, 00262464299783, 00267448219399, 00281628588099, 00289117561769, 00290237937778, 00297671949633 and 1 more |
| Serial numbers | J169457430155, J1801311367A8, J18040704DF8F, J181773679463, J18342322DF63, J185233902700, J18531602D885, J185960074278, J186478392B1E, J186751020701, J187324621476, J18793356A42C, J1879353737AC, J188283663434, J18833555314F, J1886431394B5, J188794309950, J188893710940, J188945627411, J18897822C9C3, J18909076CC90, J1891938599E3, J18951421667A, J18957760B46D, J189800136CAE and 475 more |
| Model numbers | UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1322-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.