Tag: field correction
Breas initiates correction
August 12, 2024HME News Staff
NORTH BILLERICA, Mass. – Breas Medical has initiated a 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, the company says. Short-term formaldehyde emissions may lead to adverse pulmonary or neurological effects, such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness,...
SoClean issues field correction
November 27, 2023HME News Staff
PETERBOROUGH, N.H. – SoClean on Nov. 16 issued an urgent medical device field correction that provides clarifications to the user manuals for its SoClean2 and SoClean 3 and notifies users of the availability of a hose and mask adapter for the maintenance systems.
SoClean is revising its labeling to incorporate additional warnings and contraindications, as well as proper and consistent device setup instructions, including use of a hose and mask adapter to reduce potential risks associated...