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

View original recall →
Share:

Related Recalls

2026-03-25 · FDA_DEVICE
FDA Recall: Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays m
GE Medical Systems, LLC
2026-03-25 · FDA_DEVICE
FDA Recall: Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medica
GE Medical Systems, LLC
2026-03-25 · FDA_DEVICE
FDA Recall: Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medic
GE Medical Systems, LLC