Xoran MiniCAT CT Scanner Recalled for Dose Rate Non-Compliance
Xoran Technologies is recalling 320 MiniCAT CT Scanners because they failed to meet specifications for dose rate. The devices may operate at dose rates higher or lower than required.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a technical non-compliance with specifications rather than a reported safety incident, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Xoran Technologies, Inc. is recalling 320 units of the Xoran MiniCAT CT Scanner. The recall was initiated because the devices failed to meet the manufacturer's specifications for a dose rate of 125 ± 3 kVp.
The recall is based on 18 complaints received regarding the dose rate performance of the scanners. The reported dose rates were found to be both on the high and low end of the specified range. The affected units were distributed worldwide and nationwide.
The source text does not specify the actions consumers or healthcare providers should take in response to this recall. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- Xoran MiniCAT CT Scanner
- Manufacturer
- Xoran Technologies, Inc.
- Hazard
- Affected units
- 320
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 (1)
- Minicat
Distribution
Distributed nationwide across the United States.
Related recalls
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