| Date Initiated by Firm | October 08, 2010 |
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| Date Posted | November 26, 2010 |
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| Recall Status1 |
Terminated 3 on December 30, 2010 |
| Recall Number | Z-0464-2011 |
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| Recall Event ID |
57109 |
| 510(K)Number | K092238 |
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| Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
|
| Product | DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium. |
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| Code Information |
Model 5170/100 |
Recalling Firm/
Manufacturer |
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
|
| For Additional Information Contact | Debbie Norris
864-421-1754 |
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Manufacturer Reason
for Recall | Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee. |
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FDA Determined
Cause 2 | Other |
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| Action | Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export. |
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| Quantity in Commerce | One unit |
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| Distribution | Nationside Distribution: to NJ. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
|
| 510(K) Database | 510(K)s with Product Code = MQB
|
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