Servers recalled after glitch results in radiologists reading images for wrong patients

A software malfunction has prompted the U.S. Food and Drug Administration to issue a recall on some of GE HealthCare’s image processing servers. 

The Class 2 recall pertains to the company’s AW Server 3.2 ext. 6.5. The issue could cause a reader to unintentionally report on the wrong patient, according to a notice from the FDA. 

“When a user selects a patient or exam in the AW Server Web Client work list and launches an interactive application (e.g., Volume Viewer), the application may open the previous patient's exam instead of the intended one,” the notice reads. “When this issue occurs, there is no system warning or error notification.” 

In these instances, there is a chance the reader may not notice they are interpreting the exam of the incorrect patient. This could result in misdiagnoses, incorrect clinical decisions, and delayed or improper treatment, the FDA warned. 

In May, GE issued Urgent Medical Device Correction notices to affected customers. That notice indicated that the company is working on a software fix to address the issue. In the meantime, customers can continue to use their servers, but they need to do so carefully. Users should take extra time to verify the patient identity of the exam they are reviewing and ensure it matches the requisition as well. The company encourages affected customers to spread the word to staff members who are using the server. 

The recall is small, affecting just 340 units that are distributed globally, including in the U.S. There have been no reports of adverse incidents related to the software issue. Users who have additional questions or concerns should reach out to their local GE representative or call GE HealthCare Service at 800-437-1171. 

Read more here.