Breas Medical Inc Product Recalls

Vivo 45 LS, pressure and volume ventilator capable of del... (Breas Medical, Inc.) – there is a potential for short term (... (2024)

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.

FDAJul 25, 2024Nationwide• Breas Medical, Inc.

MPV Circuit Kit (Breas Medical) – ventilation risk (2023)

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

FDAOct 13, 2023Nationwide• Breas Medical, Inc.

Breas Medical, Inc.: Vivo 45LS Ventilator- intended to provide continuous or i...

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

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Breas Medical, Inc. Recalls

Recall Summary

Vivo 45 LS, pressure and volume ventilator capable of del... (Breas Medical, Inc.) – there is a potential for short term (... (2024)

MPV Circuit Kit (Breas Medical) – ventilation risk (2023)

Breas Medical, Inc.: Vivo 45LS Ventilator- intended to provide continuous or i...

Breas Medical, Inc.: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo ...

Breas Medical, Inc.: Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part N...