Home › Device types › LSZ
Ventilator, High Frequency
FDA product code LSZ · Class 3 · Unknown
136
Registered devices
3,097
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
3100A HFOV — VYAIRE MEDICAL, INC.3100A HFOV — VYAIRE MEDICAL, INC.3100A HFOV — Carefusion Corporation3100 HFOV — VYAIRE MEDICAL, INC.3100B HFOV — VYAIRE MEDICAL, INC.3100A HFOV — VYAIRE MEDICAL, INC.3100 HFOV — VYAIRE MEDICAL, INC.3100B HFOV — Carefusion Corporation3100A HFOV — VYAIRE MEDICAL, INC.3100A HFOV — VYAIRE MEDICAL, INC.3100A HFOV — Carefusion Corporation3100A HFOV — VYAIRE MEDICAL, INC.Bunnell — BUNNELL, INCORPORATED3100 HFOV — Carefusion Corporation3100B HFOV — Carefusion Corporation3100B HFOV — VYAIRE MEDICAL, INC.3100A HFOV — Carefusion Corporation3100A HFOV — Carefusion CorporationBunnell — BUNNELL, INCORPORATED3100B HFOV — VYAIRE MEDICAL, INC.3100B HFOV — Carefusion Corporation3100A HFOV — Carefusion Corporation3100A HFOV — VYAIRE MEDICAL, INC.3100A HFOV — VYAIRE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-27 | Vyaire Medical | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distribut |
| 2023-10-27 | Vyaire Medical | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distribut |
| 2022-11-02 | Bunnell, Inc. | Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction cath |
| 2012-11-19 | Bunnell, Inc. | Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidif |
| 2010-10-25 | Bunnell, Inc. | Product software coding error may compromise patient safety. |
| 2010-10-25 | Bunnell, Inc. | Product software coding error may compromise patient safety. |
| 2005-04-04 | Bunnell, Inc. | Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase |
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