IMRIS IMRI 1 — Class II medical device recall Z-1645-2018
Terminated recall by Deerfield Imaging, Inc., reported 2018-05-16, distributed nationwide. The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the
| Recall number | Z-1645-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deerfield Imaging, Inc., Minnetonka, MN, United States |
| Recall initiated | 2018-04-04 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SE |
| Quantity | 10 units |
| Reason classes | device malfunction |
| Serial numbers | 10006-11, 10043-01, 10073-01, 10076-21, 10081-01, 10089-01, 10093-01, 10097-01, 10101-01, 10111-00 |
Product
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
Reason for recall
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.
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-1645-2018. 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.