| Date Initiated by Firm | September 05, 2006 |
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| Date Posted | October 25, 2006 |
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| Recall Status1 |
Terminated 3 on September 17, 2008 |
| Recall Number | Z-0071-2007 |
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| Recall Event ID |
36529 |
| 510(K)Number | K935694 |
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| Product Classification |
image archive system - Product Code LLZ
|
| Product | Sienet Sky, picture archiving and communications system. Model number 8463163 |
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| Code Information |
Model number 8463163, all versions. |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
|
| For Additional Information Contact | Roland Richter
610-448-4500 |
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Manufacturer Reason
for Recall | Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended. |
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FDA Determined
Cause 2 | Other |
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| Action | The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence. |
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| Quantity in Commerce | 1818 units total, for all three products |
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| Distribution | The product was shipped to medical facilities nationwide. |
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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.
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| 510(K) Database | 510(K)s with Product Code = LLZ
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