Recall Z-1210-2015— Xoran Technologies, LLC

Name: FDA recall Z-1210-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-08

Class II · Terminated

Class II FDA medical device recall by Xoran Technologies, LLC, initiated 2014-09-08, terminated 2016-02-02. It names one FDA 510(k) clearance: K113421. Product: Xoran MiniCAT X-ray imaging device. Reason: Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose..

Recalling firm: Xoran Technologies, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-09-08
Terminated: 2016-02-02
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K113421 — MINICATXoran Technologies, Inc.·cleared 2012-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Xoran MiniCAT X-ray imaging device

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.