Intelerad Medical Systems Incorporated: System, Image Processing, Radiological

Recalling firm
INTELERAD MEDICAL SYSTEMS INCORPORATED
Product
intelerad IntelePACS software
Reason
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. Additionally, a software issue has been identified that may result in the unintended deletion of image data from an external archive integration.
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-09-10
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IA, ...
Distribution
US: AL FL CO MI CA TX CT AZ NJ IL NC SC MO NH WA KY WY DC NV IN PA AK OR AR KS TN MN MD IA WI HI NY OH VA WV NM GA LA NE UT WA OUS: Australia , Canada, Ireland, New Zealand, South Africa, United Kingdom

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/74cd8049-032a-4c41-bbd5-441a7377bc8e