# FDA recall Z-0762-2020

> **Deerfield Imaging, Inc.** · Class II · device recall initiated 2019-11-26.

## Product

iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography.    The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System.  The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system.  The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging.  It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room.      The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixe

## Reason for recall

There is a potential hardware error for the iMRX System with a generator A100.  A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure.  As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible

## Distribution

CT, MA, VA.  International distribution:  Australia, Canada, and Qatar.

## Key facts

- **Recall number:** Z-0762-2020
- **Recalling firm:** Deerfield Imaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-26
- **Report date:** 2020-01-08
- **Termination date:** 2020-08-04

- **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-0762-2020

## Citation

> AI Analytics. FDA recall Z-0762-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-0762-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*