Official recall notice
FDA DeviceClass IINotable
FDA Recall: I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article num
- Recall date
- 2026-04-01
- Brand
- I.T.S. GmbH
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Recommended action
What to do
176 units
Product description
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).