Recall Z-0357-2027 ยท LLZ System, Image Processing, Radiological
INTELERAD MEDICAL SYSTEMS INCORPORATED
intelerad IntelePACS software
| Date | Nov 4, 2026 (initiated Sep 10, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On September 15, 2026 Intelerad, (a GE HealthCare Company) issued a Urgent Medical Device Correction notification to affected consignees via: email. Intelerad ask consignees to take the following actions: 1. Pending corrections by Intelerad, 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. 2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 3. Please retain this document for your records. 4. P |
| Quantity | 560 software platforms |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192176 | IntelePACS Intelerad Medical Systems Incorporated, Apr 2, 2020 |