RegWardenFDA facility compliance records
Facility

Xoran Technologies, LLC

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

Activity by year

FDA actions on record by year2009: 1 recalls; 2010: 4 recalls; 2014: 1 recalls; 2017: 1 inspections; 2024: 1 inspections, 1 warning letters1’094’10’11’12’131’14’15’161’17’18’19’20’21’22’232’24’25’26
  • Recalls (6)
  • Inspections (2)
  • Warning letters (1)

Devices registered here (3)

  • Interventional Fluoroscopic X-Ray System
    Product code OWB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
  • Image-Intensified Fluoroscopic X-Ray System, Mobile
    Product code OXO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
  • System, X-Ray, Tomography, Computed
    Product code JAK (opens in a new tab) · Class II · Radiology · 21 CFR 892.1750

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.

FDA inspections (2)

  • NAI2024-07-11
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
  • NAI2017-12-20
    No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Xoran Technologies, LLC (FEI 3004198450) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004198450-xoran-technologies-llc/

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