RegWardenFDA facility compliance records
Recall

Class II — Xoran Technologies, Inc.

Recalling firmXoran Technologies LLC
Registered facilityXoran Technologies, LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonA 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 received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu
ProductXoran MiniCAT CT Scanner
Quantity320
DistributionWorldwide Distribution - Nationwide
Initiated2010-07-27
Classified2013-10-25
Terminated2014-09-11
Recall numberZ-0037-2014
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class II recall — Xoran Technologies, Inc. (Z-0037-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66337/

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