Xoran MiniCAT X-ray devices recalled for imaging and dose defects
Xoran Technologies is recalling 432 MiniCAT X-ray imaging devices nationwide due to out-of-tolerance kVp, unexposed frames, and out-of-tolerance dose.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The defects (out-of-tolerance dose and unexposed frames) pose a risk of harm through incorrect medical imaging or radiation exposure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Xoran Technologies, LLC is recalling 432 units of the Xoran MiniCAT X-ray imaging device. The recall is due to defects where the device produces out-of-tolerance kVp, unexposed (black) frames, and out-of-tolerance dose.
The affected devices were distributed nationwide. Specific serial numbers for the recalled units are listed in the agency's recall record.
Consumers and healthcare providers should stop using the affected devices and contact Xoran Technologies for further instructions on the recall.
The recalled product
- Product
- Xoran MiniCAT X-ray imaging device
- Manufacturer
- Xoran Technologies, LLC
- Affected units
- 432
Distribution
Distributed nationwide across the United States.
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