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CLASS II · ModerateFDA

INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS

📅 Oct 17, 2025 · 📍 Nationwide
Recalling company
INTELERAD MEDICAL SYSTEMS INCORPORATED
Product
IntelePACS - InteleConnect / TechPortal
Reason
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 17, 2025
Reported
Dec 3, 2025
Distribution
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Status
Ongoing
Quantity
19
Lot / codes
UDI-DI: B228INTELEPACS0. Version/Dates of Distribution: PACS-5-6-1-R64 through R68/02 Jul 2025 - 10 Sep 2025, PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025, PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025, PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025
Company location
Montreal, N/A
Recall type
Voluntary: Firm initiated
Recall number
Z-0723-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0723-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.