Class 2 Device Recall Sienet Magicstore

• Date Initiated by Firm: May 02, 2007
• Date Posted: June 05, 2007
• Recall Status: Terminated on September 17, 2008
• Recall Number: Z-0890-2007
• Recall Event ID: 37997
• 510(K)Number: K920310
• Product Classification: Digital Image Communications/Processing system - Product Code LMD
• Product: Sienet MagicStore. Radiological Digital Image Communications System
• Code Information: Model number 7502052 Serial numbers 1793, 1804, 1867, 1920, 1966, 1968, 1983, 2055, 2099, 2527, 2601, 2610, 2618, 2632, 2635, 2638, 2678, 2686, and 2689.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-4500
• Manufacturer Reason for Recall: System could crash and result in data loss.
• FDA Determined Cause: Other
• Action: The recalling firm issued a Safety Advisory letter to their customers (May 2, 2007) to inform them of the problem. A company representative will be contacting the customers to arrange for replacement of the RAID component.
• Quantity in Commerce: 19 units
• Distribution: The products were shipped to medical facilities in CA, CO, FL, MS, NH, NJ, NY, and WA.
• 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 = LMD