An FDA Recall Record Says a Radiology Server May Open the Previous Patient's Exam Without Warning

A user picks a patient or an exam from a worklist. Then they launch an interactive application, such as a volume viewer. The application may open the previous patient's exam instead of the one they chose.

That is the fault in a medical device recall the FDA posted on June 24, 2026. The device is GE HealthCare's AW Server 3.2 ext. 6.5, a radiological image processing system. The firm began the recall on May 8, 2026. The FDA classed it as a Class 2 recall, and the record lists it as open. Its quantity in commerce is 340 servers, with worldwide distribution.

The source is the FDA's own recall record, Z-2553-2026. Its reason for the recall is the firm's own account, as the record gives it.

What the Record Says Goes Wrong

The firm calls it a "context synchronization issue." It shows up when a user selects a patient or exam in the server's web client worklist and launches an interactive application. The application may then open the previous patient's exam instead of the intended one.

When this happens, the record says, 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. That could lead to misdiagnosis and incorrect clinical decisions, the record says, resulting in delayed or incorrect treatment.

The FDA determined the cause as software design. Under FDA policy, the record notes, a recall's cause may be changed until the recall is terminated.

Pending Corrections

The firm sent customers an urgent medical device correction notice on May 8, 2026, by letter delivered via traceable means. The record quotes its instructions. Pending corrections from the firm, customers can keep using the device if they follow them.

Users should verify the correct patient identity, including name, patient ID and date of birth. They should confirm that the selected study matches the intended patient and clinical context. That check comes before they review or interpret imaging studies. Customers should make sure all potential users in their facility know of the notice and the recommended actions.

The record's status line says the recall is open. The manufacturer has started it, and not all products have been corrected or removed, a note in the record says. The record will be updated as that changes.