Recall Z-0068-2026 ยท LLZ System, Image Processing, Radiological
GE Medical Systems, SCS
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
| Date | Oct 8, 2025 (initiated Sep 5, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | 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 |
| Quantity | 7,302 (1,381 US; 5,921 OUS) |
| Distribution | Domestic US distribution nationwide. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081985 | AW SERVER Ge Medical Systems, LLC, Sep 25, 2008 |