Montreal, N/A, Canada
INTELERAD MEDICAL SYSTEMS INCORPORATED recalls
3 recalls recorded since 2018, most recently on 5 September 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 September 2026
- Reason
- Following a Chromium-based web-browser, report and displayed images may not match.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0186-2027
- IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 thro
Ongoing Class II Medical devices
- Recall started
- 17 October 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0723-2026
- IntelePACS - InteleConnect / TechPortal
Ongoing Class II Medical devices
- Recall started
- 5 February 2025
- Reason
- A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH, WY, CA, SC, AL, AR, IN, MD, CO, TN, IL, NJ, OH, MN, WV, KE, NE, VA, WA, GE, WI and the countries of New Zealand, Canada, Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1208-2025
- IntelePACS (Image Fusion Module) - InteleViewer
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.