Deerfield Imaging, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Deerfield Imaging, Inc.
Lot Codes / Batch Numbers
Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.
Products Sold
Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.
Deerfield Imaging, Inc. is recalling iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
An Urgent Field Safety Notice letter was sent to customers on 11/26/2019 via FedEx.. The letter state the issue, potential risk, the actions to be taken, and stated that the device will be modified. Questions can be directed to the service line at 1-866-475-0525.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, MA, VA
Page updated: Jan 10, 2026