| | Class 2 Device Recall Cranex Tome panoramic xray |  |
| Date Initiated by Firm | April 28, 2006 |
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| Date Posted | May 18, 2007 |
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| Recall Status1 |
Terminated 3 on February 24, 2008 |
| Recall Number | Z-0816-2007 |
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| Recall Event ID |
37838 |
| 510(K)Number | K974877 |
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| Product Classification |
panoramic x-ray - Product Code EDH
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| Product | Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland. |
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| Code Information |
Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188 |
| FEI Number |
3005383085
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Recalling Firm/
Manufacturer |
Instrumentarium Dental, Inc.
300 West Edgerton Avenue
Milwaukee
WI
53207
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Manufacturer 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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 9 |
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| Distribution | Worldwide, including USA, Canada, Bermuda, and Colombia. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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| 510(K) Database | 510(K)s with Product Code = EDH
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