FDA Medical Device Recalls (openFDA)
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 number
- Z-0816-2007
- Recalling firm
- Instrumentarium Dental, Inc.
- Product
- Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.
- Status
- Terminated
- Initiated
- 2006-04-28
- Posted
- 2007-05-18
- Terminated
- 2008-02-24
- 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.
- Lot, serial or model codes
- Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188
- 510(k) numbers
- ["K974877"]
- PMA numbers
- not on file
- Product code
- EDH
- Firm FEI
- 3005383085
- Firm city
- Milwaukee
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28