FDA Device Recall Z-0041-2014: Xoran Technologies, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-2014.

Recall Res Number

Z-0041-2014

Recalling Firm / Manufacturer

Xoran Technologies, Inc.

FEI Number

3004198450

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-12-14

Date Posted

N/A

Date Terminated

2014-09-11

Product Code

JAK

Event Number

66344

Product Quantity

320

Product Description Xoran MiniCAT CT Scanner ID ENT00001

Reason for Recall Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

Action Details The service report in response to this complaint stated that the Head select relay board, chip and fan were replaced. The machine (ENTOOOO I) was subsequently tested. All tests were successful.

Distribution Pattern Worldwide Distribution - US nationwide

Code Information / Serial Numbers minicat

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Medical Device Recall: Z-0041-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer