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BiTrac SE Select
PULMODYNE INC · Model 313-9030W · UDI-DI 00841470106720
BZD
Prescription
1
510(k) clearances
303,210
Adverse events (4,572 deaths)
83
Recalls
119
Facilities
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.