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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens KinetDx 4.2 Workplace

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  Class 2 Device Recall Siemens KinetDx 4.2 Workplace see related information
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
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
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 and Original Applicant = HEARTLAB, INC.
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