Class 2 Device Recall Brilliance iCT

• Date Initiated by Firm: July 03, 2018
• Create Date: April 13, 2019
• Recall Status: Terminated on April 17, 2020
• Recall Number: Z-1144-2019
• Recall Event ID: 80640
• 510(K)Number: K162838
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems 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: 85028 100094
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Ms. Holly Wright Lee; 440-483-2015
• Manufacturer Reason for Recall: Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
• FDA Determined Cause: Device Design
• Action: On June 29. 2018, the firm sent Customer Information Letters to affected customers. The letter informed customers that Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Customers were advised to review the user documentation provided with your system related to Quality Assurance checks. If artifacts are detected during review of the images produced by these checks, and are not removed with the recommended steps identified within your user documentation, please contact your service representative before resuming clinical use.
• Quantity in Commerce: 2
• Distribution: Distributed only to China and UK.
• 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