Class 2 Device Recall Siemens syngo Dynamics

• Date Initiated by Firm: February 08, 2008
• Date Posted: September 29, 2008
• Recall Status: Terminated on November 18, 2009
• Recall Number: Z-1751-2008
• Recall Event ID: 46823
• 510(K)Number: K070322
• Product Classification: Picture archiving and communication system - Product Code LLZ
• Product: Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
• Code Information: All units with version 6.0 software.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions, USA, Inc; 400 Morgan Rd; Ann Arbor MI 48108
• For Additional Information Contact: 734-205-2423
• Manufacturer Reason for Recall: Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.
• FDA Determined Cause: Software design
• Action: Siemens issued a customer safety advisory to users on 2/8/08 advising them of the problem and instructing them to complete and verify that the report is locked before opening and reporting on a second patient, and that a software patch will be available Spring 2008.
• Quantity in Commerce: 18
• Distribution: Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.
• 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 USA, INC.