GE Medical Systems, SCS: Device Recall
Recall #Z-0068-2026 · 09/05/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0068-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- GE Medical Systems, SCS
- Status
- Ongoing
- Date Initiated
- 09/05/2025
- Location
- Buc, France
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,302 (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.
Product Description
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Distribution Pattern
Domestic US distribution nationwide. International distribution worldwide.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.