GE Medical Imactis CT-Navigation System Recall - Discordant Needle Trajectory

FDA: Device Recalls Class II

Filed April 1st, 2026

Detected April 7th, 2026

Summary

FDA announced Class II recall of GE Medical Systems' Imactis CT-Navigation System due to potential discordance between simulated and actual needle trajectory/tip position. The recall affects Model Numbers E85101LA and E85101LP distributed nationwide. Healthcare providers using these systems should review and follow manufacturer's corrective instructions.

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What changed

GE Medical Systems, LLC initiated a Class II recall of the Imactis CT-Navigation System (Model Numbers E85101LA and E85101LP) 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 CT-guided procedures. The recall is classified as ongoing and affects devices distributed nationwide in the United States.

Healthcare providers and facilities that have these specific Imactis CT-Navigation System models in use should immediately identify affected devices, contact GE Medical Systems for corrective instructions, review any recent procedures where the system was used, and report any adverse events or patient injuries related to this issue to FDA through MedWatch. Medical device distributors should also verify their inventory and communicate recall information to end-users.

What to do next

Identify all Imactis CT-Navigation System units (Model E85101LA and E85101LP) in your facility inventory
Contact GE Medical Systems for corrective instructions and follow recall remediation procedures
Review patient records for procedures using affected devices and assess potential impact; report any adverse events to FDA via MedWatch

Source document (simplified)

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.