FDA recall Z-1590-2026

GE Medical Systems, LLC · Class II · device

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.

Key facts

Status: Ongoing
Initiation date: 2026-02-03
Report date: 2026-04-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1590-2026