CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

Xoran Minicat00158 recalled by Xoran Technologies

Xoran Technologies is recalling Xoran Minicat00158, distributed nationwide in the US. The recall was initiated on 27 Jul 2010 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesminicat

Quantity recalledN/A

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-0039-2014
FDA event ID: 66338
Recalling firm: Xoran Technologies, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 27 Jul 2010
FDA classified: 25 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Jul 2010	Recall initiated by company
25 Oct 2013	Classified by FDA	+1186 days
6 Nov 2013	Published in enforcement report	+12 days

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

Reason for recall

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 hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Xoran Minicat00158

Where it was distributed

Worldwide Distribution - US nationwide

Nationwide

Questions about this recall

Is Xoran Minicat00158 recalled?

Yes. Xoran Technologies recalled Xoran Minicat00158 on 27 Jul 2010. The recall is Class II and its status is Terminated. Recall number Z-0039-2014.

Why was it recalled?

Which lots are affected?

minicat

Where was it sold?

Worldwide Distribution - US nationwide

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
11 Mar 2015Device	CLASS II	Xoran MiniCAT X-ray imaging device recalled by Xoran Technologies	Xoran Technologies	Other	Nationwide
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

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