Food, drugs, devices › Xoran Technologies, Inc.
Device recall: Xoran Mini CT Scanner
Xoran Technologies, Inc. (Ann Arbor, MI) initiated this device recall on 27 Jul 2010; FDA lists 1 product record under event 66335, classified Class II.
FDA defines Class II as 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. 89% of the 37 device enforcement events initiated in 2010 carry the same class.
Status: Terminated, terminated 11 Sep 2014. Initiation: voluntary: firm initiated. Xoran Technologies, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Xoran Technologies, Inc., Ann Arbor, MI.
Reason for recall
"A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu"
Distribution
"Worldwide Distribution - US nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0036-2014 | Xoran Mini CT Scanner | 320 | Class II | Terminated | 6 Nov 2013 |
Context
Other enforcement events for Xoran Technologies, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jul 2010 | Xoran MiniCAT00202 | Device | Class II | 1 |
| 27 Jul 2010 | Xoran Minicat00202 | Device | Class II | 2 |
| 27 Jul 2010 | Xoran MiniCAT CT Scanner | Device | Class II | 1 |
| 14 Dec 2009 | Xoran MiniCAT CT Scanner ID ENT00001 | Device | Class II | 1 |
All 5 events for Xoran Technologies, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.