GE Medical Systems, SCS recalls AW Server 2.0

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

On September 5, 2025, firm began deployment of customer letter. Customers were informed they could continue use of their device by following the instructions provided: 1. Ensure the AW Server is installed on a facility internal network, that is not accessible from any public network. If access to AW Server from outside the facility network is desired, this connectivity must be configured to be usable exclusively through the facility s Virtual Private Network (VPN) or equivalent network security solution as described in your AW Server s Pre-Installation Manual that is available in the Customer documentation portal. NOTE: Access management to the facility s internal network on which the AW Server is installed on, and management of the network security solution is under the strict responsibility of the facility. 2. Ensure strong, secure passwords are configured for the AW Server. 3. GE HealthCare recommends that organizations follow security and cybersecurity best practices, including securing the network where AW Server is connected.

• FDA enforcement recordOfficial FDA database entry for Z-0068-2026
• FDA 510(k) clearance · K081985The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE Medical Systems, SCSSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.