Official recall notice
FDA DeviceClass IINotable
FDA Recall: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
125 units
Product 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.