Class 2 Device Recall Revolution Apex

• Date Initiated by Firm: March 26, 2026
• Date Posted: May 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2154-2026
• Recall Event ID: 98738
• 510(K)Number: K163213 K191777 K213715
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
• Code Information: UDI-DI: 00840682146616; Serial Numbers: REV2A2200014CN REV2A2200072CN REV2A2100016CN REV2A2200068CN REV2A2200034CN REV2A2200116CN REV2A2200037CN REV2A2000006CN REV2A2200041CN REV2A2100011CN REV2A2100048CN REV2A2200015CN REV2A2100038CN REV2A2200011CN REV242200002CN REV2A2200120CN REV2A2200018CN REV2A2300016CN REV2A2200067CN REV2A2000007CN REV2A2200105CN REV2A2200007CN REV2A2000032CN REV2A2100019CN
• FEI Number: 2126677
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
• FDA Determined Cause: Software design
• Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/26/26 was sent to customers. Actions to be taken by Customer/User Pending corrections by GE HealthCare, you can continue to use your system by following security and cybersecurity best practices. Before the interim solution (see Product Correction section below) is applied, please follow the instructions below as identified in the respective CT system User Manuals: CAUTION: 3D or slab reconstructions provide additional supplemental information, complementing diagnosis that should be based on classical techniques. WARNING: Do not use 3D or slab views only to perform any measurements (distance, angle, region of interest, report cursor, area, volume, etc.). Always check measurement points position and refer to 2D baseline views (acquisition images or reformatted images of minimal thickness) to confirm measurements. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via (https://gehealthcare-svc.my.site.com/publicForm/s/?formId=aGjUr000002jnD7) or print, fill out manually, scan and email to recall.23015@gehealthcare.com Product Correction GE HealthCare will correct all affected products at no cost to you in two steps. A GE HealthCare representative will contact you to arrange for an interim solution to deactivate AW Server authentication through the CT system on the EHL-based Smart Subscription, and later, to install a CT software update. Note: With the interim solution, all alternative authentication mechanisms (direct application launch from CT console user interface, login using users defined in AW Server user database, federation with hospital user directory through LDAP) will remain available. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare
• Quantity in Commerce: 24 units
• Distribution: Worldwide - US Nationwide distribution.
• 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