The Recall Desk
ModerateFDA (Devices)·Z-0037-2014·Announced 2013-11-06

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.

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, 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.
Category
Medical Device — Imaging Equipment
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

Same manufacturer · Xoran Technologies, Inc.

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