Class 2 Device Recall MagicView 1000U, version VE40A

• Date Initiated by Firm: February 28, 2003
• Date Posted: July 19, 2003
• Recall Status: Terminated on August 25, 2004
• Recall Number: Z-1029-03
• Recall Event ID: 25928
• 510(K)Number: K9355694
• Product: Magic View 1000U, version VE40A. Digital Image Communication System
• Code Information: Part number 7502003
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Parkway; Malvern PA 19355
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: software issue. New examinations may not be saved properly and the examination may be lost.
• FDA Determined Cause: Other
• Action: The recalling firm has issued a letter to their field service representative dated 2/28/02. The letter is entitled Safety Modification CN002/03/S which instructs the recalling firm's service engineers to visit each affected site and correct the software problem. A set of instructions were sent with the letter.
• Quantity in Commerce: 49 units
• Distribution: The product was shipped to medical facilities in AL, CA, CO, FL, NE, IL, IN, MI, MN, NJ, NY, OH, PA, TN, and VA.

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.