Breas Medical Recalls
5 recalls on record · March 4, 2020 to September 11, 2024 · Medical Devices
Recalls by year
20
22
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 11, 2024Medical DevicesFDA
Breas Medical, Inc. recalls Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati
Hazard: 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.
December 6, 2023Medical DevicesFDA
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 de
Hazard: 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
July 20, 2022Medical DevicesFDA
Breas Medical, Inc. recalls Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who
Hazard: 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 potentially be Permanent impairment or life threatening if medical intervention is not obtained
April 20, 2022Medical DevicesFDA
Breas Medical, Inc. recalls Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Hazard: 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 person who is in the immediate proximity
March 4, 2020Medical DevicesFDA
Breas Medical, Inc. recalls Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the V
Hazard: The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.