Device recall
Z-0164-2026: IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla…
FDA device recall · Class I · IMPRIS Imaging Inc
Key facts
| Recall number (Z-number) | Z-0164-2026 |
|---|---|
| Recall event | 97750 |
| Product | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida |
| Product code | LNH |
| Recalling firm | IMPRIS Imaging Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K083137, K101813, K133692, K212367 |
| FEI number | 3010326005 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database