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.
What this means for you
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
- 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.
Related recalls
Same manufacturer · GE Medical Systems SCS
See all →- HighMedical imaging servers recalled over security vulnerability affecting patient data
FDA (Devices) · 2025-10-15
- HighGE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall
FDA (Devices) · 2024-05-15
- HighGE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect
FDA (Devices) · 2024-05-15
- HighGE Healthcare X-Ray Systems Recalled for Loose Bolts on Gantry Assembly
FDA (Devices) · 2024-05-15
- HighGE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard
FDA (Devices) · 2024-05-15
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25