Food, drugs, devices › Deerfield Imaging, Inc.
Device recall: iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI
FDA enforcement event 84400 is a device recall by Deerfield Imaging, Inc. of Minnetonka, MN, initiated 26 Nov 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 4 Aug 2020. Initiation: voluntary: firm initiated. Deerfield Imaging, Inc. has 9 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Deerfield Imaging, Inc., Minnetonka, MN.
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"
Distribution
"CT, MA, VA. International distribution: Australia, Canada, and Qatar."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0762-2020 | 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… | 6 | Class II | Terminated | 8 Jan 2020 |
Context
Other enforcement events for Deerfield Imaging, Inc.
All 9 events for Deerfield Imaging, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "CT, MA, VA. International distribution: Australia, Canada, and Qatar."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.