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BiPAP
Respironics, Inc. · Model Circuit Filter Disp Exhal Port with FEP Filter, Single, INTL · UDI-DI 00606959042377
MNT
Prescription
10
510(k) clearances
48,849
Adverse events (250 deaths)
64
Recalls
27
Facilities
Description
CIRCUIT FILTER, DISPOSABLE EXHALATION PORT WITH FILTERED EXHALATION PORT FILTER, SINGLE, INTERNATIONAL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-09 | Philips Respironics, Inc. | This device does not indicate for use in patients with respiratory failure. |
| 2024-03-26 | Philips Respironics, Inc. | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, res |
| 2023-08-25 | Philips Respironics, Inc. | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. |
| 2023-05-15 | DRE Medical Group Inc | Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated. |
| 2022-02-28 | Respironics California, LLC | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. |
| 2022-02-28 | Respironics California, LLC | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. |
| 2022-02-28 | Respironics California, LLC | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. |
| 2022-01-24 | Respironics California, LLC | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the |
| 2022-01-24 | Respironics California, LLC | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the |
| 2021-06-18 | Respironics California, LLC | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of press |
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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.