Recall Z-0186-2027 ยท LLZ System, Image Processing, Radiological
INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; System, Image Processing, Radiological
| Date | Oct 15, 2026 (initiated Sep 5, 2026) |
| Status | Open, Classified |
| Reason | Following a Chromium-based web-browser, report and displayed images may not match. |
| Root cause | Software design |
| Action | Intelerad, a GE HealthCare company, issued an urgent medical device correction notice to its consignees on 9/5/2026 via email. This notice contained a link error and was corrected and reissued on 9/9/2026. The notice explained the issue, potential risk and requested the following: "Actions to be taken by Customer/User Pending correction by Intelerad, you can continue to use IntelePACS - InteleConnect Portal and Technologist Portal by following the instructions below: 1. Do not use Google Chrome 152 or Microsoft Edge 152 browsers to access the Physician Portal Case Viewer: a. Use Fi |
| Quantity | 317 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192176 | IntelePACS Intelerad Medical Systems Incorporated, Apr 2, 2020 |