Recall Z-0186-2027— INTELERAD MEDICAL SYSTEMS INCORPORATED

Name: FDA recall Z-0186-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-05

Class II · Ongoing

Class II FDA medical device recall by INTELERAD MEDICAL SYSTEMS INCORPORATED, initiated 2026-09-05. It names one FDA 510(k) clearance: K192176. Product: 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. Reason: Following a Chromium-based web-browser, report and displayed images may not match..

Recalling firm: INTELERAD MEDICAL SYSTEMS INCORPORATED
Classification: Class II
Status: Ongoing
Initiated: 2026-09-05
Firm location: Montreal, Canada

510(k) clearances named in this recall

1 on FDA's record

K192176 — IntelePACSIntelerad Medical Systems Incorporated·cleared 2020-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Following a Chromium-based web-browser, report and displayed images may not match.

Data sourced from openFDA. This site is unofficial and independent of the FDA.