FDA Device recall Z-0186-2027

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…

FDA Device
Class II
ongoing
Published 2026-10-21

On 2026-10-21 the FDA classified a Class II recall of 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… by Intelerad Medical Systems, citing following a Chromium-based web-browser, report and displayed images may not match.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0186-2027
Classification	Class II
Status	ongoing
Initiated	2026-09-05
Published	2026-10-21
Last updated	2026-10-27 05:30 UTC
Company	Intelerad Medical Systems
Distribution	US

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.

Identifiers

code_info	Identifier Number PACS-5-1-1-R102, HIBC Number +B228INTELEPACS0/$$75-1-1-R102C; Identifier Number PACS-5-2-1-R93, HIBC… Identifier Number PACS-5-1-1-R102, HIBC Number +B228INTELEPACS0/$$75-1-1-R102C; Identifier Number PACS-5-2-1-R93, HIBC Number +B228INTELEPACS0/$$75-2-1-R93M; Identifier Number PACS-5-3-1-R117, HIBC Number +B228INTELEPACS0/$$75-3-1-R117K; Identifier Number PACS-5-3-1-R128, HIBC Number +B228INTELEPACS0/$$75-3-1-R128M; Identifier Number PACS-5-3-1-R83, HIBC Number +B228INTELEPACS0/$$75-3-1-R83M; Identifier Number PACS-5-4-1-R101, HIBC Number +B228INTELEPACS0/$$75-4-1-R101E; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$$75-4-1-R75O; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$$75-4-1-R75O; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$$75-4-1-R75O; Identifier Number PACS-5-4-1-R82, HIBC Number +B228INTELEPACS0/$$75-4-1-R82M; Identifier Number PACS-5-4-1-R84, HIBC Number +B228INTELEPACS0/$$75-4-1-R84O; Identifier Number PACS-5-4-1-R91, HIBC Number +B228INTELEPACS0/$$75-4-1-R91M; Identifier Number PACS-5-5-1-R50, HIBC Numbe

code_info

Identifier Number PACS-5-1-1-R102, HIBC Number +B228INTELEPACS0/$$75-1-1-R102C; Identifier Number PACS-5-2-1-R93, HIBC…

Identifier Number PACS-5-1-1-R102, HIBC Number +B228INTELEPACS0/$$75-1-1-R102C; Identifier Number PACS-5-2-1-R93, HIBC Number +B228INTELEPACS0/$$75-2-1-R93M; Identifier Number PACS-5-3-1-R117, HIBC Number +B228INTELEPACS0/$$75-3-1-R117K; Identifier Number PACS-5-3-1-R128, HIBC Number +B228INTELEPACS0/$$75-3-1-R128M; Identifier Number PACS-5-3-1-R83, HIBC Number +B228INTELEPACS0/$$75-3-1-R83M; Identifier Number PACS-5-4-1-R101, HIBC Number +B228INTELEPACS0/$$75-4-1-R101E; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$$75-4-1-R75O; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$$75-4-1-R75O; Identifier Number PACS-5-4-1-R75, HIBC Number +B228INTELEPACS0/$$75-4-1-R75O; Identifier Number PACS-5-4-1-R82, HIBC Number +B228INTELEPACS0/$$75-4-1-R82M; Identifier Number PACS-5-4-1-R84, HIBC Number +B228INTELEPACS0/$$75-4-1-R84O; Identifier Number PACS-5-4-1-R91, HIBC Number +B228INTELEPACS0/$$75-4-1-R91M; Identifier Number PACS-5-5-1-R50, HIBC Numbe

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.

Other recalls by Intelerad Medical Systems

IntelePACS - InteleConnect / TechPortal
FDA Device · Class II · 2025-12-03 · Intelerad Medical Systems
IntelePACS (Image Fusion Module) - InteleViewer
FDA Device · Class II · 2025-03-05 · Intelerad Medical Systems
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sourc…
FDA Device · Class II · 2014-08-27 · Intelerad Medical Systems

All Intelerad Medical Systems recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2027%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.