Imactis CT-Navigation System
GE Medical Systems is recalling Imactis CT-Navigation System (Models E85101LA, E85101LP) due to potential needle trajectory/tip position discordance.
Contact GE Medical Systems immediately if you operate or maintain an Imactis CT-Navigation System with Model Numbers E85101LA or E85101LP. Do not use the system until you have received guidance from the manufacturer regarding verification of needle trajectory accuracy and any necessary corrective measures.
Why it was recalled
GE Medical Systems is recalling the Imactis CT-Navigation System (Model Numbers E85101LA and E85101LP), a stereotaxic accessory for CT systems, due to a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position during procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
- Recall #
- Z-1590-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from GE Medical Systems, LLC
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification