Date Initiated by Firm | February 28, 2003 |
Date Posted | August 07, 2003 |
Recall Status1 |
Terminated 3 on December 23, 2004 |
Recall Number | Z-1088-03 |
Recall Event ID |
26218 |
510(K)Number | K010938 |
Product Classification |
System, Image Processing, Radiological - Product Code LLZ
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Product | Leonardo Workstations with software version 2022A/B, 2003A |
Code Information |
Model 7129534, Serial # 01001 through 01380, 05001 through 05600, and 10001 through 10320 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Parkway Malvern PA 19355
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For Additional Information Contact | Roland Richter 610-448-1777 |
Manufacturer Reason for Recall | software problem
This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment. |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information. |
Quantity in Commerce | 1374 units |
Distribution | The product was shipped to distributors, medical facilities and Siemens training facilities nationwide. |
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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