| Date Initiated by Firm | April 06, 2006 |
|---|
| Date Posted | July 13, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 01, 2007 |
| Recall Number | Z-1235-06 |
|---|
| Recall Event ID |
35043 |
| 510(K)Number | K041029 |
|---|
| Product Classification |
System, Image Processing, Radiological - Product Code LLZ
|
| Product | KinetDx 4.0 Ultrasound Image Management System. |
|---|
| Code Information |
All units with software versions 4.0 and 4.1. |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor MI 48108
|
| For Additional Information Contact |
800-422-8766 |
|---|
Manufacturer Reason
for Recall | The cardiologist's report comments may not be retained by the system due to a software bug. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months. |
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| Quantity in Commerce | 244 |
|---|
| Distribution | Nationwide. |
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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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