RegWardenFDA facility compliance records
Company

Xoran Technologies LLC

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2009: 1 recalls; 2010: 4 recalls; 2014: 1 recalls1’094’10’11’12’131’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2014-09-08
    Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
  • Class IITerminated2010-07-27
    A description of the defect in the product or the manner in which the product fails to comply wvith 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 receive…
  • Class IITerminated2010-07-27
    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 evaluation of the…
  • Class IITerminated2010-07-27
    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 Xorans specifications.
  • Class IITerminated2010-07-27
    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 receive…
  • Class IITerminated2009-12-14
    Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Xoran Technologies LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10028111-xoran-technologies-llc/

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