Class 2 Device Recall Revolution CT, Revolution CT ES

• Date Initiated by Firm: June 30, 2021
• Create Date: July 08, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2021-2021
• Recall Event ID: 88208
• 510(K)Number: K133705 K163213 K191777
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation.; Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories.; This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results.; The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.; The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
• Code Information: Revolution CT
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Health Service; 800-437-1171
• Manufacturer Reason for Recall: When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
• FDA Determined Cause: Process design
• Distribution: US
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, L.L.C.; 510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, LLC