ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
This recall is currently active, issued April 3, 2020. It was issued by Immersivetouch Inc.
- Company
- Immersivetouch Inc
- Recall Initiated
- April 3, 2020
- Recall Number
- Z-2041-2020
- Quantity
- 2 units
- Firm Location
- Chicago, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Observed an internal repetitive software glitch in ImmersiveView.
Distribution
The device was distributed in the state of Illinois only.
Lot / Code Info
V 2.1
Root Cause
Software design
Action Taken
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.