FDA recall Z-0723-2026

INTELERAD MEDICAL SYSTEMS INCORPORATED · Class II · device

Product

IntelePACS - InteleConnect / TechPortal

Reason for recall

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.

Distribution

US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.

Key facts

Status
Ongoing
Initiation date
2025-10-17
Report date
2025-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Montreal, N/A, Canada

Primary source

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