Date Initiated by Firm |
July 13, 2006 |
Date Posted |
November 27, 2007 |
Recall Status1 |
Terminated 3 on March 13, 2008 |
Recall Number |
Z-0296-2008 |
Recall Event ID |
45529 |
510(K)Number |
K032243
|
Product Classification |
CT Scan - Product Code JAK
|
Product |
Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging. |
Code Information |
Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088. |
Recalling Firm/ Manufacturer |
Xoran Technologies, Inc. 309 N 1st St Ann Arbor MI 48103-3301
|
For Additional Information Contact |
800-709-6726
|
Manufacturer Reason for Recall |
The hard drive may crash, resulting in loss of data from patient CT scans.
|
FDA Determined Cause 2 |
Finished device change control |
Action |
Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced. |
Quantity in Commerce |
5 |
Distribution |
Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = XORAN TECHNOLOGIES, INC.
|