Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.
FDA Recall Z-0816-2007 · Posted 2007-05-18
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Recalling FirmInstrumentarium Dental, Inc.
Recall StatusTerminated
Product CodeEDH
Date Initiated2006-04-28
Date Terminated2008-02-24
Product Quantity9
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Canada, Bermuda, and Colombia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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