IMPRIS Imaging Inc
IMPRIS Imaging Inc appears in FDA public data with 4 recalls — including 4 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0163-2026, Class I) was initiated on September 30, 2025.
Summary
- Total Recalls
- 4 (4 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0163-2026 | Class I | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA | September 30, 2025 |
| Z-0164-2026 | Class I | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida | September 30, 2025 |
| Z-0162-2026 | Class I | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra | September 30, 2025 |
| Z-0161-2026 | Class I | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet | September 30, 2025 |