FDA-Device2025-12-03Class II

IntelePACS - InteleConnect / TechPortal

INTELERAD MEDICAL SYSTEMS INCORPORATED
Hazard

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.

Sold states
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Affected count
19
Manufactured in
800, Boul. de Maisonneuve Est, 12th floor, Montreal, N/A, Canada
Products
IntelePACS - InteleConnect / TechPortal

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2026

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