FDA Device

Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.

Hazard

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.

What You Should Do

Remedy

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.

Products

Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.
Brand
Instrumentarium Dental, Inc.
UPC
Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188

Units Affected

9