Intelerad IntelePACS software recalled for cybersecurity risk
Intelerad has identified a cybersecurity vulnerability in IntelePACS 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. A separate software issue may cause unintended deletion of image data from an external archive integration.
From the FDA notice · Read the official notice ↗ · All Intelerad recalls
What to do
- Check whether your IntelePACS version matches the affected list in the notice, such as PACS-5-3-1-R26 through R128.
- The notice does not specify a fix. Contact Intelerad Medical Systems for guidance on the affected version.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- intelerad IntelePACS software
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 560 software platforms
- Illnesses reported
- None reported
- Manufactured in
- 800, Boul. de Maisonneuve Est, 14th floor, Montreal, Canada
- Classification
- Class II
- Recall number
- Z-0357-2027
In the FDA's words
- Description
- intelerad IntelePACS software 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. HIBCC:B228INTELEPACS0/Affected versions: PACS-4-3-4-R20 PACS-4-9-1-R80 PACS-4-12-1-R81 through R90 PACS-4-14-1-R46 through R137 PACS-4-16-1-R50 through R137 PACS-4-17-1-R23 through R117 PACS-4-18-1-R31 through R91 PACS-5-1-1-R17 through R102 PACS-5-2-1-R36 through R93 PACS-5-3-1-R26 through R128 PACS-5-4-1-R15 through R101 PACS-5-5-1-R7 through R89 PACS-5-6-1-R12 through R81 PACS-5-7-1-R2 through R61 PACS-5-8-1-R2 through R42 PACS-5-9-1-R8 through R19 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 Affected quantity: 560 software platforms
- Hazard
- 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.
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ModerateFDAOct 21, 2026