GE Medical Systems, LLC recalls Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8

Recalled April 1, 2026 · FDA recall Z-1590-2026 · GE Medical Systems

Hazard

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

Units

125 units

Sold at

Worldwide distribution - US Nationwide.

Description

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

Product

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

Manufacturer(s)

GE Medical Systems, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →