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Revolution recallZ-2151-2026 · GE Medical Systems, LLC · initiated Mar 26, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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-2151-2026
Status
Open, Classified
Initiated by the company
Mar 26, 2026
Posted by the FDA
May 8, 2026
Recalling firm
GE Medical Systems, LLC
Quantity
33 units
Product code
JAK
FDA submissions
K213715
Distribution
Worldwide - US Nationwide distribution.

Product description

Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

Code information (models, lots, serial numbers)

UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

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

Other products in the same recall event

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

Sources and updates

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