Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250
FDA device recall Z-0816-2007 · posted 2007-05-18 · Terminated
Recall details
- Recalling firm
- Instrumentarium Dental, Inc.
- Reason for recall
- There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.
- Action taken
- A recall letter, dated 04/28/2006, was sent to affected customers . The letter describes the issue, and requests that no patient operation is permitted until the unit is checked by authorized service technician. If the service technician noted wear of the screw, the assembly was replaced.
- Root cause
- Other
- Status
- Terminated
- Product code
- EDH
- Quantity affected
- 9
- Distribution
- Worldwide, including USA, Canada, Bermuda, and Colombia.
- Date initiated
- 2006-04-28
- Date posted
- 2007-05-18
- Date terminated
- 2008-02-24
- Location
- Milwaukee, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRANEX TOME CEPH, OR CRANEX TOME (K974877) | Orion Corporation Soredex | 1998-03-27 |