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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188
Products Sold
Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188
Instrumentarium Dental, Inc. is recalling Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured b due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026