| Date Initiated by Firm | September 28, 2004 |
|---|
| Date Posted | November 03, 2004 |
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| Recall Status1 |
Terminated 3 on September 04, 2008 |
| Recall Number | Z-0163-05 |
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| Recall Event ID |
30173 |
| 510(K)Number | K010938 |
|---|
| Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
|
| Product | LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534 |
|---|
| Code Information |
Serial Numbers: 6026, 6037, 6047, 6106, 6114, 6115, 6116, and 20014 |
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 |
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Manufacturer Reason
for Recall | Calcium Scoring feature on this devices is not closing properly after patient's exams. |
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FDA Determined
Cause 2 | Other |
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| Action | The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue. |
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| Quantity in Commerce | 8 units |
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| Distribution | The product was shipped to medical facilities nationwide and government account in IL. |
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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 = JAK
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