Device recall
intelerad IntelePACS software
- Recall number
- Z-0357-2027
- Event id
- 99971
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Posted
- Nov 4, 2026
- Initiated
- Sep 10, 2026
- Product code
- LLZ
- Device type
- System, Image Processing, Radiological
- 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.
- Root cause
- Software Design Change
- Quantity
- 560 software platforms
- Code info
- 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
- Related 510(k)s
- K192176
- Location
- Montreal, Canada