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U.S. Department of Health and Human Services

Class 2 Device Recall intelerad IntelePACS software

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 Class 2 Device Recall intelerad IntelePACS softwaresee related information
Date Initiated by FirmSeptember 10, 2026
Date PostedNovember 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0357-2027
Recall Event ID 99971
510(K)NumberK192176 
Product Classification System, image processing, radiological - Product Code LLZ
Productintelerad IntelePACS software
Code Information HIBCC:B228INTELEPACS0/Affected versions: PACS-4-3-4-R20 PACS-4-9-1-R80 PACS-4-12-1-R81 through R90 PACS-4-14-1-R46 through R137 PACS-4-16-1-R50 through R137 PACS-4-17-1-R23 through R117 PACS-4-18-1-R31 through R91 PACS-5-1-1-R17 through R102 PACS-5-2-1-R36 through R93 PACS-5-3-1-R26 through R128 PACS-5-4-1-R15 through R101 PACS-5-5-1-R7 through R89 PACS-5-6-1-R12 through R81 PACS-5-7-1-R2 through R61 PACS-5-8-1-R2 through R42 PACS-5-9-1-R8 through R19
FEI Number 3003768392
Recalling Firm/
Manufacturer		 INTELERAD MEDICAL SYSTEMS INCORPORATED
800, Boul. de Maisonneuve Est
14th floor
Montreal Canada
Manufacturer Reason
for Recall		A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out of the system. Additionally, a software issue has been identified that may result in the unintended deletion of image data from an external archive integration.
FDA Determined
Cause 2		Software Design Change
ActionOn September 15, 2026 Intelerad, (a GE HealthCare Company) issued a Urgent Medical Device Correction notification to affected consignees via: email. Intelerad ask consignees to take the following actions: 1. Pending corrections by Intelerad, you can continue to use your system by continuing to follow your organization's standard cybersecurity and access control practices until the corrective update is implemented. 2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 3. Please retain this document for your records. 4. Please complete and return the attached acknowledgement form electronically via FMI 88101 Digital Response Form or email, or print, fill out manually, scan, and email to Recall.88101@gehealthcare.com.
Quantity in Commerce560 software platforms
DistributionUS: AL FL CO MI CA TX CT AZ NJ IL NC SC MO NH WA KY WY DC NV IN PA AK OR AR KS TN MN MD IA WI HI NY OH VA WV NM GA LA NE UT WA OUS: Australia , Canada, Ireland, New Zealand, South Africa, United Kingdom
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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