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
|