Class 2 Device Recall Siemens KinetDx 4.2 Workplace

• Date Initiated by Firm: July 23, 2008
• Date Posted: January 02, 2009
• Recall Status: Terminated 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: 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