| Date Initiated by Firm | September 22, 2005 |
|---|
| Date Posted | October 28, 2005 |
|---|
| Recall Status1 |
Terminated 3 on August 23, 2006 |
| Recall Number | Z-0092-06 |
|---|
| Recall Event ID |
33843 |
| 510(K)Number | K042832 |
|---|
| Product Classification |
System, Image Processing, Radiological - Product Code LLZ
|
| Product | Sienet Cosmos. Radiological Image Processing. Model number 10018971 |
|---|
| Code Information |
model number 10018971 version VB15C |
| FEI Number |
2240869
|
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
|
| For Additional Information Contact | Roland Richter
610-448-1777 |
|---|
Manufacturer Reason
for Recall | reference lines appear above actual position |
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FDA Determined
Cause 2 | Other |
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| Action | The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence. |
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| Quantity in Commerce | 64 units |
|---|
| Distribution | The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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 = LLZ
|
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