RecallRadar

FDA Device recall Z-1210-2015

Xoran MiniCAT X-ray imaging device

On 2015-03-11 the FDA classified a Class II recall of Xoran MiniCAT X-ray imaging device by Xoran Technologies, citing out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1210-2015
ClassificationClass II
Statusterminated
Initiated2014-09-08
Published2015-03-11
Last updated2026-09-13 11:53 UTC
CompanyXoran Technologies
DistributionUS

Product

Xoran MiniCAT X-ray imaging device

Reason

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

Identifiers

code_info
S/N ENT00031 MiniCAT0020 MiniCAT00361 MiniCAT00358 MiniCAT00150 MiniCAT00310 ENT00006 ENT00055 ENT00059 MiniC…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1210-2015%22

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