Xoran MiniCAT CT Scanners Recalled for Dose Rate Specification Failures
Xoran Technologies is recalling 320 MiniCAT CT Scanners because they failed to meet specifications for dose rate.
What this means for you
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a specification failure without reported harm.
Plain-English summary
Xoran Technologies, Inc. is recalling 320 units of the MiniCAT CT Scanner (model MiniCAT00202). 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 by the manufacturer. These complaints indicated that the dose rates of the affected scanners were either on the high end or the low end of the specified range. The devices were distributed worldwide and nationwide.
Consumers and healthcare providers should contact Xoran Technologies for further instructions regarding the recall. The source text does not specify specific actions for consumers beyond the recall notification.
The recalled product
- Product
- Xoran MiniCAT00202
- Manufacturer
- Xoran Technologies, Inc.
- Category
- Medical Device — CT Scanner
- 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.
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