Recall Z-0723-2026— INTELERAD MEDICAL SYSTEMS INCORPORATED

Name: FDA recall Z-0723-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-17

Class II · Ongoing

Class II FDA medical device recall by INTELERAD MEDICAL SYSTEMS INCORPORATED, initiated 2025-10-17. It names one FDA 510(k) clearance: K192176. 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..

Recalling firm: INTELERAD MEDICAL SYSTEMS INCORPORATED
Classification: Class II
Status: Ongoing
Initiated: 2025-10-17
Firm location: Montreal, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K192176 — IntelePACSIntelerad Medical Systems Incorporated·cleared 2020-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.