Class 2 Device Recall Sienet Cosmos

• Date Initiated by Firm: October 03, 2006
• Date Posted: October 25, 2006
• Recall Status: Terminated on April 23, 2008
• Recall Number: Z-0069-2007
• Recall Event ID: 36527
• 510(K)Number: K042832
• Product Classification: image archiving and communications system - Product Code LLZ
• Product: Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
• Code Information: Model number 10018969. Serial numbers 1001, 1010, 1011, 1028, 1029
• FEI Number: 2240869
• 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: Potential loss of images. Images may not successfully be sent to the RAID system.
• FDA Determined Cause: Other
• Action: The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the issue.
• Quantity in Commerce: 5 units
• Distribution: The product was shipped to hospitals in CA, MD, MO, and PA
• 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