The U.S. Food and Drug Administration (FDA) has issued a Class 2 recall for some of GE HealthCare's image processing servers due to a software malfunction that may lead to misdiagnoses. The recall affects the AW Server 3.2 ext. 6.5 due to an issue where the server could incorrectly open an exam from a previous patient instead of the intended one, without any warning. Although there have been no reported adverse incidents, the FDA cautions that this could lead to incorrect clinical decisions and improper treatment. GE is working on a software fix and has advised users to verify patient identities carefully while using the servers. The recall impacts 340 units globally and affected customers are encouraged to notify their staff. For any questions, users can contact GE HealthCare Service.
Tue, 30 Jun 2026 21:16:28 GMT | Radiology Business