Recall Z-0068-2026— GE Medical Systems, SCS

Name: FDA recall Z-0068-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-05

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, SCS, initiated 2025-09-05. It names one FDA 510(k) clearance: K081985. Product: AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2. 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..

Recalling firm: GE Medical Systems, SCS
Classification: Class II
Status: Ongoing
Initiated: 2025-09-05
Firm location: Buc, France

510(k) clearances named in this recall

1 on FDA's record

K081985 — AW SERVERGe Medical Systems, LLC·cleared 2008-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.