FDA Device recall Z-0762-2020
iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiograp…
- FDA Device
- Class II
- terminated
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiograp… by Deerfield Imaging, citing 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 gene….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0762-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-26 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Deerfield Imaging |
| Distribution | CT, MA, VA |
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
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
Identifiers
| code_info | Serial Number: 146792, 153374, 153642, 153793, 153896, 154588. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0762-2020%22
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