IntelePACS (Intelerad) – Software Communication Bug (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IntelePACS - InteleConnect / TechPortal
Brand
INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada
Lot Codes / Batch Numbers
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
Products Sold
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
INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada is recalling IntelePACS - InteleConnect / TechPortal due to Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that coul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026