Xoran Mini CT Scanner Recalled for Dose Rate Specification Failures
Xoran Technologies is recalling 320 Mini CT Scanners because they failed to meet internal specifications for dose rate, with complaints indicating rates both high and low.
What this means for you
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 involves a medical device with a defect in radiation dose rate (high and low), which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Xoran Technologies, Inc. is recalling 320 units of the Xoran Mini CT Scanner (code: Minicat). The recall is due to the devices failing to meet Xoran's specifications for a dose rate of 125 ± 3 kVp. The company received 18 complaints regarding these units, with reported dose rates falling on both the high and low ends of the specified range.
The affected scanners were distributed worldwide, including nationwide distribution in the United States. The source text does not specify the exact dates of distribution or the specific facilities where these units are installed.
Consumers and healthcare facilities should contact Xoran Technologies, Inc. for further instructions on how to address the defect. The source text does not provide specific contact details or remediation steps beyond the notification of the defect.
The recalled product
- Product
- Xoran Mini 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.
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