Z-2153-2026Class II

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

Name: Z-2153-2026 Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Creator: GE Medical Systems, LLC
Published: 2026-03-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-03-26 / Open, Classified / root cause: software

FDA source

GE Medical Systems, LLC began a recall of Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 on 2026-03-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2153-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-26
Posted: 2026-05-08
Recalling firm: GE Healthcare
Product: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA root 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 [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
Quantity in commerce: 10 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI: 00840682123471; Serial Numbers: REVV82200058CN REVV82200046CN REVV82100016CN REVV82200014CN REVV82100027CN REVV82200047CN REVV82100031CN REVV82400010CN REVV82200017CN REVV82400005CN

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2153-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2149-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2150-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2151-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2152-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2153-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2154-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08
Z-2155-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)