Xoran Minicat CT Scanners Recalled for Dose Rate Failures
Xoran Technologies is recalling Minicat CT Scanners that failed to meet specifications for dose rate, potentially affecting patient safety.
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, 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 Xoran Minicat CT Scanners. The devices subject to this recall failed to meet the manufacturer's specifications for a dose rate of 125 ± 3 kVp. The recall is based on 18 complaints received, which included dose rates on both the high and low ends of the specified range.
The distribution of these units is listed as worldwide, including nationwide distribution in the United States. The source text does not specify the exact number of units affected or the specific dates of distribution.
Consumers and healthcare facilities should contact Xoran Technologies for further instructions regarding the evaluation of hazards related to this defect.
The recalled product
- Product
- Xoran Minicat00158
- Manufacturer
- Xoran Technologies, Inc.
- Category
- Medical Device — CT Scanner
- Hazard
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.
Part of a larger recall action
This product is one of 2 recalled by Xoran Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Xoran Technologies, Inc.
See all →- ModerateXoran Minicat CT Scanners Recalled for Dose Rate Specification Failures
FDA (Devices) · 2013-11-06
- HighXoran MiniCAT CT Scanner Recalled for Gantry Rotation Failure
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- ModerateXoran MiniCAT CT Scanner Recalled for Dose Rate Non-Compliance
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- HighXoran Mini CT Scanner Recalled for Dose Rate Specification Failures
FDA (Devices) · 2013-11-06
- ModerateXoran MiniCAT CT Scanners Recalled for Dose Rate Specification Failures
FDA (Devices) · 2013-11-06
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