FDA recall Z-0068-2026

GE Medical Systems, SCS · Class II · device

Product

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

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.

Distribution

Domestic US distribution nationwide. International distribution worldwide.

Key facts

Status: Ongoing
Initiation date: 2025-09-05
Report date: 2025-10-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Buc, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2026