Reported Mar 11, 2015 · Terminated

Xoran MiniCAT X-ray imaging device

Xoran Technologies, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Xoran Technologies, LLC · 5210 S State Rd · Ann Arbor, MI · 48108-7936

Is this the product you have?

  • Xoran MiniCAT X-ray imaging device
Lot codes and dates
  • S/N
    • ENT00031
    • MiniCAT0020
    • MiniCAT00361
    • MiniCAT00358
    • MiniCAT00150
    • MiniCAT00310
    • ENT00006
    • ENT00055
    • ENT00059
    • MiniCAT00140
    • MiniCAT00305
    • ENT00014
    • MiniCAT00148
    • ENT00039
    • ENT00076
    • MiniCAT00409
    • MiniCAT00179
    • ENT00014
    • MiniCAT00215
    • MiniCAT00309
    • ENT00035
    • MiniCAT00158
    • MiniCAT00386
    • MiniCAT00202
    • MiniCAT00324
    • ENT00127
    • MiniCAT00352
    • MiniCAT00396
    • MiniCAT00194
    • ENT00080
    • MiniCAT00171
    • MiniCAT00244
Amount recalled
432

Where it was sold

  • Nationwide

Why it was recalled

Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 2, 2016 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.