Deerfield iMRX MRI and Angiography System Recalled for Hardware Error
Deerfield Imaging is recalling six iMRX MRI and Angiography Systems due to a potential hardware error in the generator A100 power supply that may prevent X-ray operation.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional failure (inability to perform X-ray) rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Deerfield Imaging, Inc. is recalling six iMRX MRI and Angiography Systems, part numbers 10094137 and 10094141, due to a potential hardware error. The affected systems are surgical/interventional suites that integrate MRI and X-ray angiography capabilities. The recall involves serial numbers 146792, 153374, 153642, 153793, 153896, and 154588.
The recall is caused by a tolerance issue in the power supply of the generator A100 control. This issue may cause the generator to fail, resulting in the X-ray tube not receiving the required voltage. Consequently, X-ray imaging may not be possible on the affected units. The FDA has classified this recall as Class II.
The affected units were distributed in Connecticut, Massachusetts, and Virginia, as well as internationally in Australia, Canada, and Qatar. Healthcare facilities and users of these systems should contact Deerfield Imaging, Inc. for further instructions on how to address the hardware error.
The recalled product
- 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…
- Manufacturer
- Deerfield Imaging, Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Serial Number: 146792
- 153374
- 153642
- 153793
- 153896
- 154588.
Distribution
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