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.