Class 2 Device Recall Brilliance Workspace Portal

• Date Initiated by Firm: February 23, 2012
• Date Posted: March 16, 2012
• Recall Status: Terminated on February 22, 2013
• Recall Number: Z-1219-2012
• Recall Event ID: 61250
• 510(K)Number: K000908
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. ; ; The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
• Code Information: Model #: 728269; Serial #s: 79901, 79902, 79903, 79904, 79905, 79906, 79907, 79910, 79911, 79912, 79913, 79914, 79916, 79917, 79918, 79920, 79921, 79922, 79923, 79924, 79925, 79926, 79927, 79928, 79929, 79930, 79931, 79932, 79934, 79935, 79936, 79937, 79939, 79940, 79942, 79943, 79944, 79945, 80002, 80005, 80006, 80007, 80009, 80010, 80011, 80025, 80026, 80027, 80031, 80032, 80037, 80039, 80040, 80041, 80042, 80047, 80053, 80054, 80056, 80058, 80059, 80060, 80061, 80062, 80063, 80065, 80066, 80067, 80068, 80069, 80070, 80071, 80072, 80073, 80075, 80076, 80077, 80078, 80079, 80080, 80081, 80082, 80084, 80085, 80086, 80087, 80088, 80091, 80093, 80094, 80095, 80096, 80097, 80098, 80109, 80110, 80111, 80112, 80113, 80114, 80115, 80116, 80117, 80119, 80121, 80123, 80128, 80129, 80130, 80133, 80134, 80137, 80139, 80140, 80141, 80143, 80145, 80146, 80147, 80148, 80149, 80150, 80151, 80152, 80153, 80154, 80155, 80156, 80157, 80158, 80160, 80161, 80162, 80163, 80164, 80165, 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• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: Joseph Vinhais; 800-722-9377
• Manufacturer Reason for Recall: Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device.
• FDA Determined Cause: Software design
• Action: The Philips Healthcare, sent an "URGENT-Medical Device Correction" Field Safety Notice dated February 08, 2012 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of their staff and to retain a copy with the equipment Instruction for Use. The letter notifies the customers that a Field Service Engineer will be contacting them to schedule a visit to implement the corrective action by installing the software update version 2.6.1. If you need further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).
• Quantity in Commerce: 822
• Distribution: Worldwide distributions: USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, VA, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WI, and WV; and countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech, Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Poland, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Venezuela.
• 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 = KPS and Original Applicant = ADAC LABORATORIES