CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

Xoran MiniCAT X-ray imaging device recalled by Xoran Technologies

Xoran Technologies is recalling Xoran MiniCAT X-ray imaging device, distributed nationwide in the US. The recall was initiated on 8 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS/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

Quantity recalled432

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1210-2015
FDA event ID: 69939
Recalling firm: Xoran Technologies, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 8 Sep 2014
FDA classified: 2 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 Sep 2014	Recall initiated by company
2 Mar 2015	Classified by FDA	+175 days
11 Mar 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Xoran MiniCAT X-ray imaging device

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Xoran MiniCAT X-ray imaging device recalled?

Yes. Xoran Technologies recalled Xoran MiniCAT X-ray imaging device on 8 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-1210-2015.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Xoran Technologies

All 7

Reported	Class	Recall	Company	Reason	Where
6 Nov 2013Device	CLASS II	Xoran Mini CT Scanner recalled by Xoran Technologies	Xoran Technologies	Device Malfunction	Nationwide
6 Nov 2013Device	CLASS II	Xoran MiniCAT CT Scanner ID ENT00001 recalled by Xoran Technologies	Xoran Technologies	Device Malfunction	Nationwide
6 Nov 2013Device	CLASS II	Xoran Minicat00202 recalled by Xoran Technologies	Xoran Technologies	Device Malfunction	Nationwide
6 Nov 2013Device	CLASS II	Xoran MiniCAT00202 recalled by Xoran Technologies	Xoran Technologies	Other	Nationwide
6 Nov 2013Device	CLASS II	Xoran MiniCAT CT Scanner recalled by Xoran Technologies	Xoran Technologies	Device Malfunction	Nationwide

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