| 2024-07-25 |
Class I
|
Ongoing |
Z-2690-2024 |
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati… |
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There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| 2023-10-13 |
Class II
|
Ongoing |
Z-0405-2024 |
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator de… |
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Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV a… |
| 2022-06-02 |
Class II
|
Ongoing |
Z-1382-2022 |
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who… |
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A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator depende… |
| 2022-03-21 |
Class II
|
Terminated |
Z-0943-2022 |
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 |
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Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ven… |
| 2020-01-28 |
Class II
|
Terminated |
Z-1352-2020 |
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the V… |
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The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. |