Class 2 Device Recall Extended Brilliance Workspace Imaging Workstation

• Date Initiated by Firm: August 02, 2004
• Date Posted: May 19, 2006
• Recall Status: Terminated on March 02, 2012
• Recall Number: Z-0889-06
• Recall Event ID: 29844
• 510(K)Number: K012009
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
• Code Information: All serial numbers. Software version 1.0 or 1.0.1
• FEI Number: 1525965
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: George X. Kambic; 440-483-2557
• Manufacturer Reason for Recall: Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
• FDA Determined Cause: Other
• Action: Revised, corrected software has been shipped to consignees beginning June, 2004.
• Quantity in Commerce: 397 devices.
• Distribution: The systems were installed at medical facilities located nationwide and worldwide.
• 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