FDA Device recall Z-2041-2020
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgica…
- FDA Device
- Class III
- ongoing
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class III recall of ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgica… by Immersivetouch, citing observed an internal repetitive software glitch in ImmersiveView.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2041-2020 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2020-04-03 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Immersivetouch |
| Distribution | IL |
Product
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Reason
Observed an internal repetitive software glitch in ImmersiveView.
Identifiers
| code_info | V 2.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2020%22
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