Class 2 Device Recall Ingenuity Core128

• Date Initiated by Firm: March 06, 2014
• Date Posted: April 16, 2014
• Recall Status: Terminated on November 05, 2014
• Recall Number: Z-1464-2014
• Recall Event ID: 67763
• 510(K)Number: K033326
• Product Classification: System, tomography,computed, emission - Product Code KPS
• Product: Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
• Code Information: System code: 728323; Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105,320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 336013 & 336015.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Mrs. Kumudini J. Carter; 440-483-3032
• Manufacturer Reason for Recall: A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
• FDA Determined Cause: Software in the Use Environment
• Action: .The firm, Phillips, sent an " URGENT ¿¿ Medical Device Correction" letter dated 2013 March 06, to its costumers . The letter disc ribes the product, problem and actions to be taken. The costumers were instructed to Verify that all planned image reconstructions are completed, and Perform off-line reconstructions if expected images are missing. The firm will release A Field Change Order (FCO) to correct the issue with software version release 3.5.7.and A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any 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: 116 units
• Distribution: Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.
• 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 = PHILIPS MEDICAL SYSTEMS, INC.