Recall Z-0723-2026 ยท LLZ System, Image Processing, Radiological
INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS - InteleConnect / TechPortal
| Date | Nov 26, 2025 (initiated Oct 17, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| 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 regulatory-affairs@intelerad.com. For more information or to ask any questi |
| Quantity | 19 |
| Distribution | US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192176 | IntelePACS Intelerad Medical Systems Incorporated, Apr 2, 2020 |