GE Medical Systems, LLC recalls Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E…

Recall date

February 3, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1590-2026

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide distribution - US Nationwide.

Why it was recalled

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

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

What was recalled

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP