Date Initiated by Firm | July 23, 2008 |
Date Posted | January 02, 2009 |
Recall Status1 |
Terminated 3 on October 18, 2010 |
Recall Number | Z-0543-2009 |
Recall Event ID |
49457 |
510(K)Number | K040896 |
Product Classification |
Image Processing Radiological System - Product Code LLZ
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Product | Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235.
Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information. |
Code Information |
All units. |
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 | If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report. |
FDA Determined Cause 2 | Software design |
Action | Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available. |
Quantity in Commerce | 306 of all products. |
Distribution | Nationwide Distribution. |
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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