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DreamStation
Respironics, Inc. · Model DreamStation BiPAP Pro w/Humid w/H Tube, w/Cell, AHP · UDI-DI 00606959025509
BZD
Prescription
10
510(k) clearances
304,176
Adverse events (4,571 deaths)
83
Recalls
119
Facilities
Description
DreamStation BiPAP Pro with Humidifier, with Heated Tube, with Cellular Modem, American Home Patient (AHP)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-11 | CooperSurgical, Inc. | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly redu |
| 2026-08-11 | CooperSurgical, Inc. | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly redu |
| 2025-06-30 | Philips Respironics, Inc. | Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-06-30 | Philips Respironics, Inc. | Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-06-30 | Philips Respironics, Inc. | Devices may possess a programming error resulting in an incorrect device configuration. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.