Z-0816-2007

Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX...

Name: Z-0816-2007 Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX...
Creator: Instrumentarium Dental, Inc.
Published: 2006-04-28
License: https://open.fda.gov/license/

Palodex Group Oy / initiated 2006-04-28 / Terminated

FDA source

Instrumentarium Dental, Inc. began a recall of Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland on 2006-04-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0816-2007
Status: Terminated
Initiated: 2006-04-28
Posted: 2007-05-18
Terminated: 2008-02-24
Recalling firm: Palodex Group Oy
Product: Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.
Product code: EDH
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.
FDA 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 in commerce: 9
Distribution: Worldwide, including USA, Canada, Bermuda, and Colombia.
Product codes and lots: Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188

Product code EDH

K974877Class IICranex Tome Ceph, or Cranex TomeOrion Corporation Soredex / cleared 1998-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)