iMRX MRI and Angiography System — Class II medical device recall Z-0762-2020
Terminated recall by Deerfield Imaging, Inc., reported 2020-01-08, distributed in CT, MA, VA. There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power
| Recall number | Z-0762-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deerfield Imaging, Inc., Minnetonka, MN, United States |
| Recall initiated | 2019-11-26 |
| Classified | 2019-12-31 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2020-08-04 |
| Distributed | CT, MA, VA |
| Countries outside the US | AU, CA, QA |
| Quantity | 6 |
| Serial numbers | 146792, 153374, 153642, 153793, 153896, 154588 |
| Model numbers | 10094137, 10094141 |
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 fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.
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
Machine access
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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.