FDAFDA recall Z-0186-2027 · Oct 21, 2026

INTELERAD MEDICAL SYSTEMS INCORPORATED: IntelePACS recall

Recall found

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 for recall

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

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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: 317 units
Distribution: US Nationwide distribution.
Recalling firm: INTELERAD MEDICAL SYSTEMS INCORPORATED, Montreal
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-09-05

Source: openFDA enforcement record Z-0186-2027 · search recall number Z-0186-2027 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.