IMPRIS Imaging Inc
Medical device manufacturer in Chaska, MN.
0510(k) clearances
0PMA approvals
4recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0164-2026 Class I | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI…There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | 09/30/2025Open, Classified |
| Z-0163-2026 Class I | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDAThere is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | 09/30/2025Open, Classified |
| Z-0162-2026 Class I | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, SkyraThere is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | 09/30/2025Open, Classified |
| Z-0161-2026 Class I | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla…There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | 09/30/2025Open, Classified |