Breas Medical Issues Voluntary U.S. Nationwide Urgent Medical Device Correction of Vivo 45 LS Ventilator
On August 5, 2024, Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Short term formaldehyde emissions m
Source: Food and Drugs Administration--Recalls/Safety Alerts