FDAFebruary 28, 2023device
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
What to do
FDA enforcement status: Ongoing
Brands named
omega medical imagingomegaomega medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membra...2026-05-11
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