Device product
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Z-2041-2020
Product summary
- Event
- Event 85475
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2041-2020
Official wording
Reason: Observed an internal repetitive software glitch in ImmersiveView.
Code information: V 2.1
Distribution pattern: The device was distributed in the state of Illinois only.
Derived failure modes
-
Unknown
Observed an internal repetitive software glitch in ImmersiveView.