FDAClass IIMarch 11, 2015

Xoran MiniCAT X-ray imaging device recall

Xoran MiniCAT X-ray imaging device

Why was Xoran MiniCAT X-ray imaging device recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

Product
Xoran MiniCAT X-ray imaging device
Recalling firm
Xoran Technologies, LLC
Quantity
432
Distribution
Nationwide Distribution
Recall date
March 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls