Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

FDA Recall Z-0068-2026 · Posted 2025-10-08

Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2025-09-05
Product Quantity7,302 (1,381 US; 5,921 OUS)

Reason for Recall

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.

Firm 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 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.

Root Cause

Software in the Use Environment

Distribution Pattern

Domestic US distribution nationwide. International distribution worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑