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

2026-06-17 · FDA_DEVICE
FDA Recall: Allia IGS 5 Pulse angiographic X-ray system
GE Medical Systems, LLC
2026-06-17 · FDA_DEVICE
FDA Recall: Allia Moveo angiographic X-ray system
GE Medical Systems, LLC
2026-06-17 · FDA_DEVICE
FDA Recall: Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems, LLC
2026-06-17 · FDA_DEVICE
FDA Recall: Allia IGS 7 Pulse angiographic X-ray system
GE Medical Systems, LLC