Class 2 Device Recall Brilliance 64, Brilliance Big Bore, Brilliance iCT, Brilliance iCT SP, Ingenuity CT

• Date Initiated by Firm: October 07, 2011
• Date Posted: January 24, 2012
• Recall Status: Terminated on June 18, 2013
• Recall Number: Z-0845-2012
• Recall Event ID: 60873
• 510(K)Number: K033357 K033326 K060937
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland, OH. ; ; Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
• Code Information: Model #'s - Brilliance 64: 728231, Ingenuity CT: 728326, iCT: 728306; iCT SP: 728311 & Brilliance Big Bore: 728243
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: 440-483-7000
• Manufacturer Reason for Recall: The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state
• FDA Determined Cause: Software design
• Action: On 10/10/2011 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected products, the problem, the hazard involved, the action to be taken by the customer, and actions planned by Philips. Customers were to reboot their systems if the two possible scenarios occurred. Philips Healthcare plans on installing the update through a Field Change Order free of charge. For further information or support concerning the issue, contact a local Philips representative or local Philips Healthcare office. In North America and Canada, contact Customer Care Solutions Center at 1-800-722-9377, option 5.
• Quantity in Commerce: 548 units
• Distribution: Worldwide Distribution -- USA, including the states of: AL, AZ, CA, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA & WV and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BANGLADESH, BELGIUM, Brazil, CHINA, COLUMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LUXEMBOURG, MALAYSIA, MALI, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, QATAR, RUSSIA, SINGAPORE, SLOVENIA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN & VIETNAM.
• 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 and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.