Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sin
FDA device recall Z-0296-2008 · posted 2007-11-27 · Terminated
Recall details
- Recalling firm
- Xoran Technologies, Inc.
- Reason for recall
- The hard drive may crash, resulting in loss of data from patient CT scans.
- Action taken
- Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 5
- Distribution
- Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.
- Date initiated
- 2006-07-13
- Date posted
- 2007-11-27
- Date terminated
- 2008-03-13
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINICAT DENTOCAT (K032243) | Xoran Technologies, Inc. | 2003-10-02 |