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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- communication-failure
- therapy-settings-error
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.
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