PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 15, 2025 Initiated: September 5, 2025 #Z-0068-2026

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.

Details

Recalling Firm
GE Medical Systems, SCS
Units Affected
7,302 (1,381 US; 5,921 OUS)
Distribution
Domestic US distribution nationwide. International distribution worldwide.
Location
Buc

Frequently Asked Questions

What product was recalled?
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2. Recalled by GE Medical Systems, SCS. Units affected: 7,302 (1,381 US; 5,921 OUS).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 15, 2025. Severity: Moderate. Recall number: Z-0068-2026.