Z-2553-2026Class II

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

Name: Z-2553-2026 GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Creator: GE Medical Systems SCS
Published: 2026-05-08
License: https://open.fda.gov/license/

GE Medical Systems SCS / initiated 2026-05-08 / Open, Classified / root cause: software

FDA source

GE Medical Systems SCS began a recall of GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System on 2026-05-08. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g...". 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-2553-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-08
Posted: 2026-06-24
Recalling firm: GE Medical Systems SCS
Product: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 5/8/2026 by letter delivered via traceable means. The notice explained the issue, potential risk to patient, and requested the following: "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the device by following the instructions below: " Ensure that users verify the correct patient identity (including name, patient ID, and date of birth) and confirm that the selected study matches the intended patient and clinical context prior to reviewing or interpreting imaging studies. 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 this FMI 80193 Digital CRF or print, fill out manually, scan, and email to [email protected]." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 340 servers
Distribution: Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam.
Product codes and lots: REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2553-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2553-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code LLZ

K081985Class IIAw ServerGe Medical Systems, LLC / cleared 2008-09-25

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)