Recall Z-2041-2020 ยท LLZ System, Image Processing, Radiological
Immersivetouch Inc
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
| Date | Apr 3, 2020 |
| Status | Open, Classified |
| Reason | Observed an internal repetitive software glitch in ImmersiveView. |
| Root cause | Software design |
| Action | ImmersiveTouch, Inc., notified customers on 04/03/2020 via email titled "Notification of ImmersiveView 2.1 Update". The email informed the customers that the firm will update the software from version 2.1 to 3.0. |
| Quantity | 2 units |
| Distribution | The device was distributed in the state of Illinois only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140860 | ImmersiveTouch3 and MicrovisTouch Immersivetouch, Dec 16, 2014 |