device · product 1 of 1
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.
- Recall number
- Z-1322-2023
- Initiated
- February 10, 2023
- Classification
- Class I
- Status
- Ongoing
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 1233 devices
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Inspect official wording and provenance
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.
Code information
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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Distribution pattern
US Nationwide. France, Reunion.