Breas Medical recalls
4 official recalls and safety alerts involving Breas Medical since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Breas Medical or the relevant agency.
- 2024-09-11
USBreas Medical, Inc. recalls Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require…
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.
- 2023-12-06
- US
Breas Medical, Inc. recalls with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS.…
Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
- 2022-07-20
- US
Breas Medical, Inc. recalls Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require…
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 dependent patient are NOT followed, the health consequences could…
- 2022-04-20
- US
Breas Medical, Inc. recalls Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
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 ventilator to fall from the trolley and cause injury to a…