# FDA recall Z-1645-2018

> **Deerfield Imaging, Inc.** · Class II · device recall initiated 2018-04-04.

## 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.

## Distribution

Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada

## Key facts

- **Recall number:** Z-1645-2018
- **Recalling firm:** Deerfield Imaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-04
- **Report date:** 2018-05-16
- **Termination date:** 2020-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minnetonka, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2018

## Citation

> AI Analytics. FDA recall Z-1645-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1645-2018. Source: US FDA. Licensed CC0.

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