GE Medical Systems, LLC

Device Recalls (Class II)

← All Device Recalls (Class II)
Class II Z-1590-2026 · 20260401 · Ongoing

Product

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

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.

Source: openFDA Enforcement API