Recall Z-0816-2007 ยท EDH
Instrumentarium Dental, Inc.
Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.
| Date | May 18, 2007 (initiated Apr 28, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 9 |
| Distribution | Worldwide, including USA, Canada, Bermuda, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974877 | CRANEX TOME CEPH, OR CRANEX TOME Orion Corporation Soredex, Mar 27, 1998 |