Medical device recalls Moderate risk

GE Medical Systems, SCS recalls AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

Recall date
September 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0068-2026
FDA classification
Class II
Brand / firm
GE Medical Systems, SCS
Sold / distributed
Domestic US distribution nationwide. International distribution worldwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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