Recall Z-0723-2026
Intelerad Medical Systems Incorporated · initiated October 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IntelePACS - InteleConnect / TechPortal
Codes / lots: 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
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.
FDA-determined 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
Details
- Recall number
- Z-0723-2026
- Initiated
- October 17, 2025
- Posted by FDA
- November 26, 2025
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 19
- Distribution
- US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
- Recalling firm
- Intelerad Medical Systems Incorporated, Montreal