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U.S. Department of Health and Human Services

Class 3 Device Recall KinetDx

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  Class 3 Device Recall KinetDx see related information
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.
Quantity in Commerce 244
Distribution Nationwide.
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 = SIEMENS MEDICAL SOLUTIONS, INC.
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