Cybersecurity vulnerability prompts recall of popular PACS software
The U.S. Food and Drug Administration has issued a Class 2 recall for popular picture archiving and communication system software used by practices globally.
A Nov. 4 notice from the agency indicates that the recall was issued due to a “cybersecurity vulnerability” with IntelePACS—a software product from Intelerad Medical Systems Inc.
“A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out of the system,” the notice reads. “Additionally, a software issue has been identified that may result in the unintended deletion of image data from an external archive integration.”
Intelerad, a GE HealthCare company, issued Urgent Medical Device Correction notices to affected customers in September. The notifications indicate that customers could continue to use the software with extra cybersecurity awareness. The company informed users that it is working on implementing corrections.
“You can continue to use your system by continuing to follow your organization's standard cybersecurity and access control practices until the corrective update is implemented,” the notice stated.
It is estimated that around 560 users are affected, with the software deployed globally.
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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.