Class II

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

GE Medical Systems, LLC · February 3, 2026

Reason for Recall

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

Distribution

Worldwide distribution - US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

125 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1590-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

GE Medical Systems, LLC Medical Device Recall: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP | SafeCheck