IntelePACS - InteleConnect / TechPortal
This recall is currently active, issued November 26, 2025. It was issued by Intelerad Medical Systems Incorporated 800, Boul. De Maisonneuve Est 12Th Floor Montreal Canada.
- Company
- Intelerad Medical Systems Incorporated 800, Boul. De Maisonneuve Est 12Th Floor Montreal Canada
- Recall Initiated
- October 17, 2025
- Posted
- November 26, 2025
- Recall Number
- Z-0723-2026
- Quantity
- 19
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: B228INTELEPACS0. Version/Dates of Distribution: PACS-5-6-1-R64 through R68/02 Jul 2025 - 10 Sep 2025, PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025, PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025, PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025
Root Cause
Software Design Change
Action Taken
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 questions about the notification contact the firm's regulatory affairs department at regulatory-affairs@intelerad.com