Philips DreamStation respiratory devices recalled for communication issues affecting prescription settings
Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, the agency's most serious classification. While no deaths or illnesses are reported, the Class I designation reflects the serious potential for therapeutic failure in a critical respiratory device.
Plain-English summary
Philips is recalling a limited number of DreamStation Auto BiPAP and CPAP devices used to treat obstructive sleep apnea. The recalled models include UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, and UFRX500S14.
These devices may experience communication issues when connecting to Philips' cloud-based care management application. This communication failure may prevent the device from downloading updated prescription settings from the care provider.
When prescription settings cannot be properly downloaded or are incorrect, the device may deliver incorrect therapy settings to the patient, potentially compromising the effectiveness of treatment for obstructive sleep apnea.
Patients using affected devices should contact Philips Respironics or their healthcare provider to determine if their device serial number is on the recall list and to obtain guidance on remediation or replacement.
The recalled product
- 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.
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 1,233
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN/HIBC: HIBCUCDSX500S11
- GTINUDSX500S11F
- HIBCUDSX700S11
- GTINUDSX700S11F
- GTINUFRX500S14
- Serial Numbers: J24421197E010
- J201506009824
- J20558590552C
- J21032984C317
- J21209966AF9A
- J217958772FC0
- J232909614499
- J232986192AC6
- J239466352C09
- J26991149FC9E
- J285824687E46
- J169457430155
- J18040704DF8F
- J181773679463
- J18342322DF63
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips Respironics, Inc.
See all →- SevereTrilogy EV300 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy EV300 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · communication failure
See all →- ModeratePhilips Telemetry Monitor 5500 Device Reset Risk Recall
FDA (Devices) · 2026-07-01
- SevereEnhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator
FDA (Devices) · 2025-05-07
- ModerateBeckman Coulter DxI 9000 Analyzer Communication Failure Recall
FDA (Devices) · 2025-03-26
- HighHospital Bed Fails to Send Remote Alerts Through Nurse Call System
FDA (Devices) · 2024-11-06
- HighMedtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer
FDA (Devices) · 2024-10-30
Similar recalls
- SevereDreamStation Auto CPAP units may hold an incorrect device configuration
FDA (Devices) · 2025-08-20
- SevereDreamStation Auto BiPAP units may hold an incorrect device configuration
FDA (Devices) · 2025-08-20
- SeverePhilips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing
FDA (Devices) · 2022-09-14
- SeverePhilips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk
FDA (Devices) · 2022-09-14
- SeverePhilips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing
FDA (Devices) · 2022-09-14
- SeverePhilips Respironics ventilators recalled due to foam degradation and chemical release
FDA (Devices) · 2021-07-21