The Recall Desk
HighFDA (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.

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
Category
Medical Device — Radiological Image Processing System
Hazard
  • software-defect
  • patient-misidentification
  • misdiagnosis-risk

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 category