Medical device recalls Moderate risk

Omega Medical Imaging, Inc. recalls Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

Recall date
September 8, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0160-2024
FDA classification
Class II
Brand / firm
Omega Medical Imaging, Inc.
Sold / distributed
Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma

Why it was recalled

An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

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