Agency classClass IIOur severity:High FDA (Devices)·Z-2553-2026·Announced 2026-07-01

GE Healthcare AW Server Radiological Image Processing System Software Defect

GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a risk-of-harm scenario (potential misdiagnosis and incorrect clinical decisions due to wrong patient images being displayed). Although no illnesses or injuries have been reported, the hazard is not merely theoretical—the source explicitly describes the chain of events that could lead to patient harm (wrong images displayed → unrecognized error → misdiagnosis → delayed/incorrect treatment). Under the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).

Plain-English summary

GE Healthcare has issued a recall of the AW Server 3.2 ext. 6.5 radiological image processing system. The system is affected by a context synchronization issue in which a user selecting a patient or exam in the Web Client worklist and launching an interactive application—such as Volume Viewer—may inadvertently open the previous patient's exam instead of the intended one.

The primary concern is that this error occurs without any system warning or error notification. If a clinical user does not recognize the mistake, they could review, interpret, or report medical images for the wrong patient. This could result in misdiagnosis, incorrect clinical decisions, and delayed or incorrect treatment for the affected patient.

Approximately 340 servers have been distributed worldwide, including throughout the United States and in numerous countries globally. Healthcare facilities using the AW Server 3.2 ext. 6.5 should contact GE Healthcare for guidance on how to address this issue.

Users who suspect they may have encountered this synchronization problem should review their recent image interpretation activities and patient records to verify they were working with the correct patient's imaging data.

The recalled product

Product: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Manufacturer: GE Medical Systems SCS
Category: Medical Device — Radiological Image Processing System
Hazard: software-defect
patient-misidentification
misdiagnosis-risk
Affected units: 340

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

REF# (01)00840682102384(10)AWS03D02E6D5
GTIN Number 00840682102384

Distribution

Distributed nationwide across the United States.

Same manufacturer · GE Medical Systems SCS

See all →

High
Medical imaging servers recalled over security vulnerability affecting patient data
FDA (Devices) · 2025-10-15
High
GE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall
FDA (Devices) · 2024-05-15
High
GE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect
FDA (Devices) · 2024-05-15
High
GE Healthcare X-Ray Systems Recalled for Loose Bolts on Gantry Assembly
FDA (Devices) · 2024-05-15
High
GE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard
FDA (Devices) · 2024-05-15

Same hazard · software defect