CLASS II Device recall · Reported 8 Jan 2020 · FDA Enforcement Report
iMRX MRI and Angiography System recalled by Deerfield Imaging
Deerfield Imaging is recalling iMRX MRI and Angiography System, distributed nationwide in the US. The recall was initiated on 26 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0762-2020
- FDA event ID
- 84400
- Recalling firm
- Deerfield Imaging, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2019
- FDA classified
- 31 Dec 2019
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 26 Nov 2019 | Recall initiated by company | |
| 31 Dec 2019 | Classified by FDA | +35 days |
| 8 Jan 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
CT, MA, VA. International distribution: Australia, Canada, and Qatar.
Questions about this recall
Is iMRX MRI and Angiography System recalled?
Yes. Deerfield Imaging recalled iMRX MRI and Angiography System on 26 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0762-2020.
Why was it recalled?
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
Which lots are affected?
Serial Number: 146792, 153374, 153642, 153793, 153896, 154588.
Where was it sold?
CT, MA, VA. International distribution: Australia, Canada, and Qatar.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Deerfield Imaging
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trumpf Mount Clamp Assembly (table adapter component) recalled | Deerfield Imaging | Other | Nationwide |
| Device | CLASS II | Operating room table recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Operating room table recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Operating room table recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Imris MR/X-ray head fixation device recalled by Deerfield Imaging | Deerfield Imaging | Device Malfunction | FL, NH, TN |
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