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Parker Quality & Compliance

PQC Reg Watch

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Device 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-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

FDA recall source

Recall number
Z-0186-2027
Event id
99899
Status
Ongoing
FDA classification
Class II
Recalling firm
INTELERAD MEDICAL SYSTEMS INCORPORATED
Report date
Oct 21, 2026
Posted
Oct 15, 2026
Initiated
Sep 5, 2026
Center classification date
Oct 15, 2026
Product code
LLZ
Device type
System, Image Processing, Radiological
Reason
Following a Chromium-based web-browser, report and displayed images may not match.
Root cause
Software design
Quantity
317 units
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.
Distribution
US Nationwide distribution.
Voluntary or mandated
Voluntary: Firm initiated
Related 510(k)s
K192176
Location
Montreal, Canada