Revolution recallZ-2153-2026 · GE Medical Systems, LLC · initiated Mar 26, 2026

Why it was recalled

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 root cause category: Software design

What the company is doing

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 [email protected] 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

Recall details

Recall number

Z-2153-2026

Status

Open, Classified

Initiated by the company

Mar 26, 2026

Posted by the FDA

May 8, 2026

Recalling firm

GE Medical Systems, LLC

Quantity

10 units

Product code

JAK

FDA submissions

K163213, K191777, K213715

Distribution

Worldwide - US Nationwide distribution.

Product description

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Revolution CT ES

  GE Medical Systems, L.L.C. · System, x-ray, tomography, computed
  5 recalls0 reports

Product lines

• RevolutionGE Medical Systems, L.L.C. · 7 models · 1 reports · 14 recalls

Other devices under the same FDA submission

4 devices cleared under K163213, K191777, K213715 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Revolution Apex

  GE Medical Systems, L.L.C. · System, x-ray, tomography, computed
  6 recalls0 reports
• Revolution Apex Plus

  GE Medical Systems, L.L.C. · System, x-ray, tomography, computed
  2 recalls1 report
• Revolution Apex Select

  GE Hangwei Medical Systems Company Ltd. · System, x-ray, tomography, computed
  2 recalls0 reports
• Revolution CT with Apex edition

  GE Medical Systems, L.L.C. · System, x-ray, tomography, computed
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 98738).

• Z-2149-2026 · Open, Classified
  Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
• Z-2150-2026 · Open, Classified
  Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
• Z-2151-2026 · Open, Classified
  Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
• Z-2152-2026 · Open, Classified
  Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
• Z-2154-2026 · Open, Classified
  Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
• Z-2155-2026 · Open, Classified
  Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27