GE Medical Systems, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
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
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →