GE HealthCare recalls certain CT systems due to 'security vulnerability'
The U.S. Food and Drug Administration has issued a Class 2 recall for a series of computed tomography systems manufactured by GE Medical Systems.
The recall is due to a potential “security vulnerability” within the systems’ servers, according to an FDA notice.
“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,” the notice reads.
Only the Revolution series is believed to be affected by the software issue. GEHC was made aware of the problem back in March. At that time, the company issued Urgent Medical Device Correction letters to impacted customers. The messages informed customers that they could continue to use the systems in conjunction with cybersecurity best practices. GE HealthCare also included information on how to best operate the systems safely until corrective actions are taken.
Around 200 systems in operation globally are believed to be affected by the recall, which comes just two months after another glitch prompted GEHC to issue Urgent Medical Device Correction letters due to potential security concerns with some of the company's monitors. In both cases, GEHC has acted proactively to address the issues to ensure sensitive data remain protected. Neither recall has been associated with any reported security breaches.
Affected customers with questions or concerns are encouraged to contact their GE HealthCare service representative for additional information.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.