FDAFDA · Food and drugs·Recall number Z-2149-2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Published May 20, 2026 · Recall initiated: March 26, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems, LLC
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- UDI-DI: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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