FDA DeviceClass IINotable

FDA Recall: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num

Date: 2026-04-01
Brand: GE Medical Systems, LLC
Category: Medical Device
FDA Class: Class II

Description

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Hazard

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Remedy

125 units

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