Device product

Xoran MiniCAT X-ray imaging device

Z-1210-2015

September 08, 2014

Class II

Product summary

Firm: Xoran Technologies, LLC
Event: Event 69939
Status: Terminated
Classification: Class II
Quantity: 432
Official record key: device-enforcement:Z-1210-2015

Official wording

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

Code information: 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

Distribution pattern: Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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