Class 2 Device Recall IntelePACS

• Date Initiated by Firm: September 05, 2026
• Date Posted: October 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0186-2027
• Recall Event ID: 99899
• 510(K)Number: K192176
• Product Classification: System, image processing, radiological - Product Code LLZ
• 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
• Code Information: 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.
• FEI Number: 3003768392
• Recalling Firm/ Manufacturer: INTELERAD MEDICAL SYSTEMS INCORPORATED; 800, Boul. de Maisonneuve Est; 12th floor; Montreal Canada
• Manufacturer Reason for Recall: Following a Chromium-based web-browser, report and displayed images may not match.
• FDA Determined 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 Recall.88102@gehealthcare.com." For questions or concerns regarding this notification, please contact Intelerad at Recall.88102@gehealthcare.com.
• Quantity in Commerce: 317 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ