Xoran MiniCAT CT Scanner Recalled for Gantry Rotation Failure
Xoran Technologies is recalling 320 MiniCAT CT Scanners because the gantry may fail to rotate while emitting radiation.
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 involves a medical device where a mechanical failure could lead to unintended radiation exposure. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Xoran Technologies, Inc. is recalling 320 units of the Xoran MiniCAT CT Scanner (ID ENT00001). The recall is due to a reported failure of the scanner's gantry to rotate. The distribution pattern is listed as worldwide, including US nationwide.
The specific hazard identified is that the scanner may emit radiation while the gantry is not rotating. This condition was alleged in a complaint regarding the device's operation.
Consumers and healthcare facilities with this specific model should contact Xoran Technologies for instructions on how to proceed with the recall.
The recalled product
- Product
- Xoran MiniCAT CT Scanner ID ENT00001
- Manufacturer
- Xoran Technologies, Inc.
- 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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