ImmersiveView software version 2 — Class III medical device recall Z-2041-2020
Ongoing recall by Immersivetouch Inc, reported 2020-05-27, distributed in IL. Observed an internal repetitive software glitch in ImmersiveView.
| Recall number | Z-2041-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immersivetouch Inc, Chicago, IL, United States |
| Recall initiated | 2020-04-03 |
| Classified | 2020-05-18 |
| Reported by FDA | 2020-05-27 |
| Distributed | IL |
| Quantity | 2 units |
| Reason classes | software |
Product
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Reason for recall
Observed an internal repetitive software glitch in ImmersiveView.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2041-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.