IntelePACS - InteleConnect / TechPortal
FDA Recall Z-0723-2026 · Posted 2025-11-26
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Recalling FirmINTELERAD MEDICAL SYSTEMS INCORPORATED
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2025-10-17
Product Quantity19
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.
Firm Action
On 10/17/2025, correction notices were emailed to customers who were asked to do the following:
1. Schedule Feature Release Upgrade (FRU) update immediately with the firm's
Customer Success Manager (CSM).
2. Interim Mitigation: Until the update is applied, please advise all staff to verify the 'Relevant Clinical Info' field after any Case Editor modifications and consider temporarily documenting critical clinical information in alternative fields as backup.
3. complete and return the Acknowledgement Form via email to [email protected].
For more information or to ask any questions about the notification contact the firm's
regulatory affairs department at [email protected]
Root Cause
Software Design Change
Distribution Pattern
US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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