Class 2 Device Recall Brilliance BigBore Radiology CT

• Date Initiated by Firm: February 23, 2017
• Create Date: March 20, 2017
• Recall Status: Terminated on February 26, 2019
• Recall Number: Z-1493-2017
• Recall Event ID: 76683
• 510(K)Number: K033357
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance BigBore Radiology CT - 728244; 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
• Code Information: System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique Device Identifier 76058 (01)00884838059450(21)76058 76033 (01)00884838059450(21)76033 76048 (01)00884838059450(21)76048 76059 (01)00884838059450(21)76059 76015 (01)00884838059450(21)76015 76063 (01)00884838059450(21)76063 76066 (01)00884838059450(21)76066 76049 (01)00884838059450(21)76049 76040 (01)00884838059450(21)76040 76032 (01)00884838059450(21)76032 76061 (01)00884838059450(21)76061 76031 (01)00884838059450(21)76031 76006 (01)00884838059450(21)76006 76041 (01)00884838059450(21)76041 76035 (01)00884838059450(21)76035 76038 (01)00884838059450(21)76038 76065 (01)00884838059450(21)76065 76064 (01)00884838059450(21)76064 76053 (01)00884838059450(21)76053 76050 (01)00884838059450(21)76050 76060 (01)00884838059450(21)76060 76036 (01)00884838059450(21)76036 76056 (01)00884838059450(21)76056 76055 (01)00884838059450(21)76055 76037 (01)00884838059450(21)76037 76051 (01)00884838059450(21)76051 76044 (01)00884838059450(21)76044 76039 (01)00884838059450(21)76039 76012 (01)00884838059450(21)76012 76026 (01)00884838059450(21)76026 760016 (01)00884838059450(21)760016 760001 (01)00884838059450(21)760001 760005 (01)00884838059450(21)760005 760004 (01)00884838059450(21)760004 760003 (01)00884838059450(21)760003 760007 (01)00884838059450(21)760007 76072 (01)00884838059450(21)76072 76062 (01)00884838059450(21)76062 76043 (01)00884838059450(21)76043 760013 (01)00884838059450(21)760013 760014 (01)00884838059450(21)760014 76029 (01)00884838059450(21)76029 760010 (01)00884838059450(21)760010 76027 (01)00884838059450(21)76027 760011 (01)00884838059450(21)760011 760009 (01)00884838059450(21)760009 760006 (01)00884838059450(21)760006 76045 (01)00884838059450(21)76045 76054 (01)00884838059450(21)76054 76069 (01)00884838059450(21)76069 76034 (01)00884838059450(21)76034 76030 (01)00884838059450(21)76030 76047 (01)00884838059450(21)76047 76057 (01)00884838059450(21)76057 76028 (01)00884838059450(21)76028 76068 (01)00884838059450(21)76068 760012 (01)00884838059450(21)760012 760002 (01)00884838059450(21)760002
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Ms. Holly Wright Lee; 440-483-5777
• Manufacturer Reason for Recall: Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
• FDA Determined Cause: Software design
• Action: Philips sent an Urgent Field Safety Notice dated February 24, 2017, to all affected consignee's via certified mail with returned receipts for tracking purposes. Philips Key Market representatives will distribute the notices internationally. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Implementation of the software update will be monitored. Consignees requiring further information or support concerning this issue were instructed to contact their local Philips representative. For North America and Canada, contact the Customer Care Solutions Center at 1-800-722-9377.
• Quantity in Commerce: 67
• Distribution: Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, 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 = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.