Drug recall
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI…
FDA recall event 79816 · Class II · Deerfield Imaging, Inc.
Key facts
| Event ID | 79816 |
|---|---|
| Recall numbers | Z-1645-2018 |
| Recalling firm | Deerfield Imaging, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 4, 2018 |
| Report date | May 16, 2018 |
| Termination date | Jul 22, 2020 |
| City | Minnetonka |
| State | MN |
| Country | United States |
| FEI number | 3010326005 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: