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U.S. Department of Health and Human Services

Class 2 Device Recall IntelePACS

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 Class 2 Device Recall IntelePACSsee related information
Date Initiated by FirmOctober 17, 2025
Date PostedNovember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0723-2026
Recall Event ID 97868
510(K)NumberK192176 
Product Classification System, image processing, radiological - Product Code LLZ
ProductIntelePACS - InteleConnect / TechPortal
Code Information 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
Recalling Firm/
Manufacturer		 INTELERAD MEDICAL SYSTEMS INCORPORATED
800, Boul. de Maisonneuve Est
12th floor
Montreal Canada
Manufacturer 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 2		Software Design Change
ActionOn 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
Quantity in Commerce19
DistributionUS Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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