Medical device recalls Moderate risk

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

Recall date
February 28, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0156-2024
FDA classification
Class II
Brand / firm
Omega Medical Imaging, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the country of Pakistan.

Why it was recalled

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.

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, Part Number 1000-0085

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