Class 2 Device Recall BRILLIANCE VOLUME

• Date Initiated by Firm: December 22, 2008
• Date Posted: June 29, 2009
• Recall Status: Terminated on September 24, 2010
• Recall Number: Z-1582-2009
• Recall Event ID: 52214
• 510(K)Number: K060937
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
• Code Information: Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: Unknown; 440-483-7000
• Manufacturer Reason for Recall: Software anomaly. An artifact may appear in brain scans and brain perfusion studies, when using 80kV and a UA, UB, or UC filter with this CT scanning device.
• FDA Determined Cause: Software design
• Action: An "URGENT - Field Safety Notice" dated December 22, 2009 was issued via certified mail to affected customers. The letter described the affected product, problem, hazards involved, and actions for customers to take. Philips will provide customers with a software update for all affected systems within next 6 months. The firm also sent a second notification in the form of an "URGENT -Medical Device Correction" report dated January 29, 2009 which contained information noted in the "URGENT - Field Safety Notice". Direct questions to your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.
• Quantity in Commerce: 44
• Distribution: Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.
• 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 = JAK