FDA-Device2026-10-21Class IIPROCESSING DEFECT
IntelePACS medical imaging system recalled for image display mismatch
What this means
IntelePACS, a medical imaging system used in hospitals and clinics, has a software issue where displayed images may not match the printed reports when using certain web browsers. This could lead to confusion during diagnosis or patient care if a clinician relies on mismatched information.
- If your facility uses IntelePACS, contact IntelRad Medical Systems for a software update or patch
- Verify that displayed images match reports before finalizing any diagnostic decisions
- Check the FDA recall notice for your specific system version and HIBC number
The agency's original wording
Hazard
Following a Chromium-based web-browser, report and displayed images may not match.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
317 units
Manufactured in
800, Boul. de Maisonneuve Est, 12th floor, Montreal, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0186-2027Want us to check the next one for you?
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