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...
Intelerad Medical Systems Incorporated / initiated 2026-09-05 / Open, Classified
Recall record
- Recall number
- Z-0186-2027
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Intelerad Medical Systems Incorporated
- 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
- Product code
- LLZ System, Image Processing, Radiological
- Reason for recall
- Following a Chromium-based web-browser, report and displayed images may not match.
- FDA root cause
- Software design
- Action
- Intelerad, a GE HealthCare company, issued an urgent medical device correction notice to its consignees on 9/5/2026 via email. This notice contained a link error and was corrected and reissued on 9/9/2026. The notice explained the issue, potential risk and requested the following: "Actions to be taken by Customer/User Pending correction by Intelerad, you can continue to use IntelePACS - InteleConnect Portal and Technologist Portal by following the instructions below: 1. Do not use Google Chrome 152 or Microsoft Edge 152 browsers to access the Physician Portal Case Viewer: a. Use Firefox or Safari as the browser. b. Use an earlier version of the Chrome/Edge browser (versions preceding Google Chrome 152 and Microsoft Edge 152) 2. If you cannot use Firefox or Safari or an earlier version of the Chrome/Edge browser, always refresh the browser web page after opening each exam/study to ensure the correct report is displayed. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via email or print, fill out manually, scan, and email to [email protected]." For questions or concerns regarding this notification, please contact Intelerad at [email protected].
- Quantity in commerce
- 317 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- 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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.