Class II Recall

IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS

Summary

The FDA issued a Class II for IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2- by INTELERAD MEDICAL SYSTEMS INCORPORATED. Reason: Following a Chromium-based web-browser, report and displayed images may not match..

Details

Source

Device Recall

External ID

Z-0186-2027

Action Date

2026-10-21

Status

Ongoing

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

Lot/Code Info: 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 Number +B228INTELEPACS0/$$75-5-1-R50I; Identifier Number PACS-5-5-1-R53, HIBC Number +B228INTELEPACS0/$$75-5-1-R53L; Identifier Number PACS-5-5-1-R60, HIBC Number +B228INTELEPACS0/$$75-5-1-R60J; Identifier Number PACS-5-6-1-R40, HIBC Number +B228INTELEPACS0/$$75-6-1-R45N; Identifier Number PACS-5-6-1-R43, HIBC Number +B228INTELEPACS0/$$75-6-1-R43L; Identifier Number PACS-5-6-1-R44, HIBC Number +B228INTELEPACS0/$$75-6-1-R44M; Identifier Number PACS-5-6-1-R52, HIBC Number +B228INTELEPACS0/$$75-6-1-R52L; Identifier Number PACS-5-6-1-R52, HIBC Number +B228INTELEPACS0/$$75-6-1-R52L; Identifier Number PACS-5-6-1-R52, HIBC Number +B228INTELEPACS0/$$75-6-1-R52L; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R57, HIBC Number +B228INTELEPACS0/$$75-6-1-R57Q; Identifier Number PACS-5-6-1-R58, HIBC Number +B228INTELEPACS0/$$75-6-1-R58R; Identifier Number PACS-5-6-1-R58, HIBC Number +B228INTELEPACS0/$$75-6-1-R58R; Identifier Number PACS-5-6-1-R58, HIBC Number +B228INTELEPACS0/$$75-6-1-R58R; Identifier Number PACS-5-6-1-R59, HIBC Number +B228INTELEPACS0/$$75-6-1-R59S; Identifier Number PACS-5-6-1-R59, HIBC Number +B228INTELEPACS0/$$75-6-1-R59S; Identifier Number PACS-5-6-1-R60, HIBC Number +B228INTELEPACS0/$$75-6-1-R60K; Identifier Number PACS-5-6-1-R60, HIBC Number +B228INTELEPACS0/$$75-6-1-R60K; Identifier Number PACS-5-6-1-R62, HIBC Number +B228INTELEPACS0/$$75-6-1-R62M; Identifier Number PACS-5-6-1-R62, HIBC Number +B228INTELEPACS0/$$75-6-1-R62M; Identifier Number PACS-5-6-1-R62, HIBC Number +B228INTELEPACS0/$$75-6-1-R62M; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R63, HIBC Number +B228INTELEPACS0/$$75-6-1-R63N; Identifier Number PACS-5-6-1-R69, HIBC Number +B228INTELEPACS0/$$75-6-1-R69T; Identifier Number PACS-5-6-1-R74, HIBC Number +B228INTELEPACS0/$$75-6-1-R74P; Identifier Number PACS-5-6-1-R76, HIBC Number +B228INTELEPACS0/$$75-6-1-R76R; Identifier Number PACS-5-6-1-R76, HIBC Number +B228INTELEPACS0/$$75-6-1-R76R; Identifier Number PACS-5-6-1-R79, HIBC Number +B228INTELEPACS0/$$75-6-1-R79U; Identifier Number PACS-5-6-1-R81, HIBC Number +B228INTELEPACS0/$$75-6-1-R81N; Identifier Number PACS-5-7-1-R21, HIBC Number +B228INTELEPACS0/$$75-7-1-R21I; Identifier Number PACS-5-7-1-R22, HIBC Number +B228INTELEPACS0/$$75-7-1-R22J; Identifier Number PACS-5-7-1-R27, HIBC Number +B228INTELEPACS0/$$75-7-1-R27O; Identifier Number PACS-5-7-1-R31, HIBC Number +B228INTELEPACS0/$$75-7-1-R31J; Identifier Number PACS-5-7-1-R31, HIBC Number +B228INTELEPACS0/$$75-7-1-R31J; Identifier Number PACS-5-7-1-R31, HIBC Number +B228INTELEPACS0/$$75-7-1-R31J; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R32, HIBC Number +B228INTELEPACS0/$$75-7-1-R32K; Identifier Number PACS-5-7-1-R34, HIBC Number +B228INTELEPACS0/$$75-7-1-R34M; Identifier Number PACS-5-7-1-R36, HIBC Number +B228INTELEPACS0/$$75-7-1-R36O; Identifier Number PACS-5-7-1-R36, HIBC Number +B228INTELEPACS0/$$75-7-1-R36O; Identifier Number PACS-5-7-1-R38, HIBC Number +B228INTELEPACS0/$$75-7-1-R38Q; Identifier Number PACS-5-7-1-R39, HIBC Number +B228INTELEPACS0/$$75-7-1-R39R; Identifier Number PACS-5-7-1-R39, HIBC Number +B228INTELEPACS0/$$75-7-1-R39R; Identifier Number PACS-5-7-1-R39, HIBC Number +B228INTELEPACS0/$$75-7-1-R39R; Identifier Number PACS-5-7-1-R41, HIBC Number +B228INTELEPACS0/$$75-7-1-R41K; Identifier Number PACS-5-7-1-R41, HIBC Number +B228INTELEPACS0/$$75-7-1-R41K; Identifier Number PACS-5-7-1-R44, HIBC Number +B228INTELEPACS0/$$75-7-1-R44N; Identifier Number PACS-5-7-1-R48, HIBC Number +B228INTELEPACS0/$$75-7-1-R48R; Identifier Number PACS-5-7-1-R51, HIBC Number +B228INTELEPACS0/$$75-7-1-R51L; Identifier Number PACS-5-7-1-R51, HIBC Number +B228INTELEPACS0/$$75-7-1-R51L; Identifier Number PACS-5-7-1-R51, HIBC Number +B228INTELEPACS0/$$75-7-1-R51L; Identifier Number PACS-5-7-1-R51, HIBC Number +B228INTELEPACS0/$$75-7-1-R51L; Identifier Number PACS-5-7-1-R52, HIBC Number +B228INTELEPACS0/$$75-7-1-R42L; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R54, HIBC Number +B228INTELEPACS0/$$75-7-1-R54O; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R56, HIBC Number +B228INTELEPACS0/$$75-7-1-R56Q; Identifier Number PACS-5-7-1-R57, HIBC Number +B228INTELEPACS0/$$75-7-1-R57R; Identifier Number PACS-5-7-1-R57, HIBC Number +B228INTELEPACS0/$$75-7-1-R57R; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R59, HIBC Number +B228INTELEPACS0/$$75-7-1-R59T; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R60, HIBC Number +B228INTELEPACS0/$$75-7-1-R60L; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-7-1-R61, HIBC Number +B228INTELEPACS0/$$75-7-1-R61M; Identifier Number PACS-5-8-1-R11, HIBC Number +B228INTELEPACS0/$$75-8-1-R11I; Identifier Number PACS-5-8-1-R27, HIBC Number +B228INTELEPACS0/$$75-8-1-R27P; Identifier Number PACS-5-8-1-R29, HIBC Number +B228INTELEPACS0/$$75-8-1-R29R; Identifier Number PACS-5-8-1-R29, HIBC Number +B228INTELEPACS0/$$75-8-1-R29R; Identifier Number PACS-5-8-1-R29, HIBC Number +B228INTELEPACS0/$$75-8-1-R29R; Identifier Number PACS-5-8-1-R30, HIBC Number +B228INTELEPACS0/$$75-8-1-R30J; Identifier Number PACS-5-8-1-R32, HIBC Number +B228INTELEPACS0/$$75-8-1-R32L; Identifier Number PACS-5-8-1-R32, HIBC Number +B228INTELEPACS0/$$75-8-1-R32L; Identifier Number PACS-5-8-1-R32, HIBC Number +B228INTELEPACS0/$$75-8-1-R32L; Identifier Number PACS-5-8-1-R34, HIBC Number +B228INTELEPACS0/$$75-8-1-R34N; Identifier Number PACS-5-8-1-R34, HIBC Number +B228INTELEPACS0/$$75-8-1-R34N; Identifier Number PACS-5-8-1-R34, HIBC Number +B228INTELEPACS0/$$75-8-1-R34N; Identifier Number PACS-5-8-1-R35, HIBC Number +B228INTELEPACS0/$$75-8-1-R35O; Identifier Number PACS-5-8-1-R36, HIBC Number +B228INTELEPACS0/$$75-8-1-R36P; Identifier Number PACS-5-8-1-R36, HIBC Number +B228INTELEPACS0/$$75-8-1-R36P; Identifier Number PACS-5-8-1-R37, HIBC Number +B228INTELEPACS0/$$75-8-1-R37Q; Identifier Number PACS-5-8-1-R37, HIBC Number +B228INTELEPACS0/$$75-8-1-R37Q; Identifier Number PACS-5-8-1-R37, HIBC Number +B228INTELEPACS0/$$75-8-1-R37Q; Identifier Number PACS-5-8-1-R37, HIBC Number +B228INTELEPACS0/$$75-8-1-R37Q; Identifier Number PACS-5-8-1-R39, HIBC Number +B228INTELEPACS0/$$75-8-1-R39S; Identifier Number PACS-5-8-1-R40, HIBC Number +B228INTELEPACS0/$$75-8-1-R40K; Identifier Number PACS-5-8-1-R40, HIBC Number +B228INTELEPACS0/$$75-8-1-R40K; Identifier Number PACS-5-8-1-R40, HIBC Number +B228INTELEPACS0/$$75-8-1-R40K; Identifier Number PACS-5-8-1-R42, HIBC Number +B228INTELEPACS0/$$75-8-1-R42M; Identifier Number PACS-5-8-1-R42, HIBC Number +B228INTELEPACS0/$$75-8-1-R42M; Identifier Number PACS-5-8-1-R42, HIBC Number +B228INTELEPACS0/$$75-8-1-R42M; Identifier Number PACS-5-8-1-R42, HIBC Number +B228INTELEPACS0/$$75-8-1-R42M; Identifier Number PACS-5-8-1-R6, HIBC Number +B228INTELEPACS0/$$75-8-1-R6M; Identifier Number PACS-5-9-1-R13, HIBC Number +B228INTELEPACS0/$$75-9-1-R13L; Identifier Number PACS-5-9-1-R13, HIBC Number +B228INTELEPACS0/$$75-9-1-R13L; Identifier Number PACS-5-9-1-R8, HIBC Number +B228INTELEPACS0/$$75-9-1-R8P.

Quantity Affected: 317 units

Reason for Recall

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

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-05

Company

INTELERAD MEDICAL SYSTEMS INCORPORATED

Montreal

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.

INTELERAD MEDICAL SYSTEMS INCORPORATED has 3 FDA actions in our database, including 3 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (INTELERAD MEDICAL SYSTEMS INCORPORATED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does INTELERAD MEDICAL SYSTEMS INCORPORATED have FDA actions?

INTELERAD MEDICAL SYSTEMS INCORPORATED has 3 FDA actions in our database, including 3 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0186-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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