Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 8, 2020
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
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 gen…
Deerfield Imaging, Inc. recalled iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventi… — a moderate-severity action.
iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventi… was recalled by Deerfield Imaging, Inc. in January 8, 2020. Reason: There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the powe…. Check the official notice for the remedy. Verify recall #Z-0762-2020 with the FDA Devices before acting.
The recall
Deerfield Imaging, Inc. issued this moderate-severity FDA Devices recall — There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the powe….
- Moderate
- severity level
- 6 units
- affected scope
- Class II
- classification
- January 8, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0762-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0762-2020) was formally reported on January 8, 2020, with the manufacturer initiating the action on November 26, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Deerfield Imaging, Inc. is listed as the recalling firm, operating out of Minnetonka, MN. Federal records list the affected scope as 6.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: CT, MA, VA. International distribution: Australia, Canada, and Qatar.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
6
Related Recalls
6
6 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0762-2020 |
| Date reported | January 8, 2020 |
| Date initiated | November 26, 2019 |
| Recalling firm | Deerfield Imaging, Inc. |
| Firm location | Minnetonka, MN |
| Affected scope | 6 |
| Distribution | CT, MA, VA. International distribution: Australia, Canada, and Qatar. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0762-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Deerfield Imaging, Inc.. Units affected: 6.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2020. Severity: Moderate. Recall number: Z-0762-2020.
Where was the recalled product distributed? ▼
Distribution: CT, MA, VA. International distribution: Australia, Canada, and Qatar..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0762-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 8, 2020.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.