Class 2 Device Recall Leonardo

• Date Initiated by Firm: October 11, 2002
• Date Posted: May 16, 2003
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-0841-03
• Recall Event ID: 26082
• 510(K)Number: K010938
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Leonardo MM-WS systems. System, Image Processing.
• Code Information: Model Number 7129534
• FEI Number: 2240869
• 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: Perfusion CT is displaying a higher gray and color values than normal. A software problem.
• FDA Determined Cause: Other
• Action: Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.
• Quantity in Commerce: 2
• Distribution: The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.
• 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